drug information update - performrx information update march...aliskiren hemifumarate 150 mg, 300 mg...
TRANSCRIPT
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TABLE OF CONTENTS
TABLE OF CONTENTS ............................................................................... 1
NEWLY AVAILABLE GENERICS ................................................................. 2
NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS ............................... 3
NEW INDICATIONS (EXISTING DRUGS) .................................................... 5
FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS .............................. 8
STUDIES AND RECENT TOPICS ............................................................... 16
RECALLS ................................................................................................ 20
CURRENT DRUG SHORTAGES .............................................................. 124
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NEWLY AVAILABLE GENERICS
GENERIC DRUG NAME STRENGTH &
DOSAGE FORM GENERIC
MANUFACTURER BRAND NAME
TREPROSTINIL SODIUM
1 MG/ML, 2.5 MG/ML, 5 MG/ML,
10 MG/ML VIAL
SANDOZ REMODULIN
VIT E/LIDOCAINE/ALOE/COLLAGEN 2 % GEL MPM MEDICAL REGENECARE
RANOLAZINE 500 MG,
1000 MG ER TABLET
LUPIN PHARMACEUTICAL
RANEXA
BENZHYDROCODONE/ ACETAMINOPHEN
6.12 MG-325 MG, 8.16 MG-325 MG, 4.08 MG-325 MG
TABLET
KVK-TECH, INC. APADAZ
CYCLOBENZAPRINE HCL 15 MG,
30 MG ER CAPSULE
TEVA USA, IMPAX/AMNEAL,
TWI PHARMACEUTICAL
AMRIX
CINACALCET HCL 30 MG, 60 MG,
90 MG TABLET
CIPLA USA, INC. SLATE RUN PHARM
SENSIPAR
GELATIN SPONGE, ABSORB/PORCINE 100 CM SPONGE PHARMACI/PFIZER
ETHICON GELFOAM
COMPRESSED
GELATIN SPONGE, ABSORB/PORCINE 12-7 MM SPONGE PHARMACI/PFIZER
ETHICON GELFOAM
LIDOCAINE HCL 4% GEL W/PUMP GENSCO
LABORATORY ASTERO
DICLOFENAC EPOLAMINE 1.3% PATCH TEVA USA
GREENSTONE LLC. FLECTOR
ALISKIREN HEMIFUMARATE 150 MG,
300 MG TABLET PRASCO LABS TEKTURNA
METHEN/MBLUE/SAL/ SOD PHOS/HYOS
120 MG-10 MG-36 MG-40.8 MG-0.12
MG CAPSULE BIOCOMP PHARMA USTELL
PYRIDOSTIGMINE BROMIDE 60 MG/5 ML
SYRUP NOVITIUM PHARMA
MESTINON
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NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS
DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES
ANTIPSORIATIC AGENTS, SYSTEMIC
TREMFYA GUSELKUMAB 100 MG/ML AUTO INJCT
New Dosage Form
THYROID HORMONES TIROSINT-SOL LEVOTHYROXINE
SODIUM
13 MCG/ML 25 MCG/ML 50 MCG/ML 75 MCG/ML 88 MCG/ML
100 MCG/ML 112 MCG/ML 125 MCG/ML 137 MCG/ML 150 MCG/ML 175 MCG/ML 200 MCG/ML
ORAL SOLUTION
New Dosage Form
OPIOID ANTITUSSIVE-1ST GENERATION ANTIHISTAMINE
TUXARIN ER CHLORPHENIRAMINE
/CODEINE PHOS 8MG-54.3MG
TABLET ER 12H New
Combination
LEUKOCYTE (WBC) STIMULANTS
NIVESTYM FILGRASTIM-AAFI 300 MCG/ML VIAL 480MCG/1.6 VIAL
New Strength, New Dosage
Form
EYE ANTI-INFLAMMATORY
AGENTS LOTEMAX SM
LOTEPREDNOL ETABONATE
0.38 % DROPS GEL
New Strength
AGENTS TO TX THROMBOTIC
THROMBOCYTOPENIC PURPURA
CABLIVI CAPLACIZUMAB-
YHDP 11 MG KIT New Entity
ANTINEOPLASTIC-CD123-DIRECTED
CYTOTOXIN CONJUGATE ELZONRIS TAGRAXOFUSP-ERZS
1000 MCG/ML IV SOLUTION
New Entity
ANTIDEPRESSANT - NMDA RECEPTOR
ANTAGONIST SPRAVATO ESKETAMINE HCL
56 MG, 84 MG NASAL SPRAY
New Entity
HEMORRHOID PREP, ANTI-INFLAM STEROID-
LOCAL ANESTHET
LIDOCAINE-HYDROCORT-
ISONE
LIDOCAINE/ HYDROCORTISONE
AC
2%-2% KIT (CREAM, WIPES)
New Strength
TOPICAL PREPARATIONS,ANTIBAC
TERIALS SOLOX GEL SILVER NITRATE 55 PPM GEL
New Dosage Form & Strength
OPHTHALMIC PREPARATIONS, MISCELLANEOUS
HEALON ENDOCOAT
HYALURONATE SODIUM
30 MG/ML INTRAOCULR
SYRINGE New Strength
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DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES
NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE
ANALGESICS
QMIIZ ODT MELOXICAM 7.5 MG, 15 MG TABLET RAPDIS
New Dosage Form
ANTI-PROGRAMMED CELL DEATH-LIGAND 1
(PD-L1) MAB TECENTRIQ ATEZOLIZUMAB
840 MG/14 ML VIAL
New Package Size
IMMUNOSUPPRESSIVES PROGRAF TACROLIMUS 0.2 MG, 1 MG
ORAL GRANULE PACK
New Dosage Form and Strength
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NEW INDICATIONS (EXISTING DRUGS)
LONSURF®
February 25, 2019
Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has
approved LONSURF® as a treatment for adult patients with metastatic gastric or gastroesophageal
junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included
a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted
therapy.
Source: Taiho Oncology, Inc.
SOLIQUA® 100/33
February 27, 2019
The U.S. Food and Drug Administration (FDA) has approved the expanded use of Soliqua® 100/33
(insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL. Previously approved for use as
an add-on to diet and exercise in adults with type 2 diabetes who are uncontrolled on long-acting insulin
or lixisenatide, Soliqua 100/33 can now also be prescribed for patients uncontrolled on oral antidiabetic
medicines.
Source: Sanofi
HERCEPTIN HYLECTA™
February 28, 2019
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S.
Food and Drug Administration (FDA) has approved Herceptin Hylecta™ (trastuzumab and hyaluronidase-
oysk) for subcutaneous (under the skin) injection for the treatment of certain people with HER2-positive
early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature)
in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with
paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic
disease. This new treatment includes the same monoclonal antibody as intravenous Herceptin®
(trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to
deliver trastuzumab under the skin. Herceptin Hylecta is a ready-to-use formulation that can be
administered in two to five minutes, compared to 30 to 90 minutes for intravenous Herceptin.
Source: Genentech
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ADHANSIA XR™
March 1, 2019
Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug
Administration (FDA) approved Adhansia XR™ (methylphenidate hydrochloride) extended-release
capsules CII, a central nervous system (CNS) stimulant, for the treatment of Attention-
Deficit/Hyperactivity Disorder (ADHD) in patients six years and older. In a simulated Adult Workplace
Environment (AWE) study, Adhansia XR demonstrated statistically significant improvement over placebo
at 1, 2, 5, 8, 11, and 16 hours post-dose, but not at hour 14 post-dose.
Source: Adlon Therapeutics L.P.
SPRAVATO™
March 5, 2019
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug
Administration (FDA) has approved SPRAVATO™ (esketamine) CIII nasal spray for use in conjunction with
an oral antidepressant in adults with treatment- resistant depression (TRD). People who are currently
struggling with major depressive disorder (MDD) are considered to have TRD if they have not responded
adequately to at least two different antidepressants of adequate dose and duration in the current
depressive episode. It is estimated that approximately one-third of U.S. adults with MDD have TRD.4
SPRAVATO™ carries a Boxed WARNING regarding a Risk Evaluation and Mitigation Strategy (REMS) and
the risk of suicidal thoughts and behaviors in pediatric patients and young adults.
Source: Janssen Pharmaceutical Companies
TECENTRIQ®
March 8, 2019
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S.
Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq® (atezolizumab) plus
chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-
bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic
triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-
approved test. This indication is approved under accelerated approval based on progression-free
survival (PFS). Continued approval for this indication may be contingent upon verification and
description of clinical benefit in a confirmatory trial(s). The FDA’s Accelerated Approval Program allows
conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening
disease or condition.
Source: Genentech
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DUPIXENT®
March 11, 2019
The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for adolescent
patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not
adequately controlled with topical prescription therapies, or when those therapies are not advisable.
Dupixent can be used with or without topical corticosteroids.
Source: Sanofi
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FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS
Losartan distributed by Macleods Pharmaceuticals voluntarily recalled
[Posted 2/25/2019]
FDA is alerting patients and health care professionals to a voluntary recall of one lot of losartan
potassium/hydrochlorothiazide (HCTZ) 100mg/25mg combination tablets manufactured by Macleods
Pharmaceuticals. The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) found in
the medicine made with active pharmaceutical ingredient manufactured by Hetero Labs Limited.
Macleods is only recalling lots of losartan-containing medication where NDEA has been detected above
the interim acceptable intake limit of 0.27 parts per million. FDA is working with manufacturers to
reduce and remove nitrosamines from angiotensin II receptor blockers (ARBs).
The agency also updated the list of losartan products under recall.
Source: U.S. Food and Drug Administration (FDA)
Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients
[Posted 2/25/2019]
ISSUE: FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis
BACKGROUND: When FDA first approved tofacitinib, we required a clinical trial among patients with RA
to evaluate the risk of heart-related events, cancer, and opportunistic infections with the medicine at
two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to
another drug called a tumor necrosis factor (TNF) inhibitor. RA patients in the trial were required to be
at least 50 years old and have at least one cardiovascular risk factor. During the most recent analysis of
the trial, an external data safety monitoring committee found an increased occurrence of blood clots in
the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated
with tofacitinib 5 mg twice daily or a TNF inhibitor.
RECOMMENDATION: Health care professionals should follow the recommendations in the tofacitinib
prescribing information for the specific condition they are treating. Monitor patients for the signs and
symptoms of pulmonary embolism, and advise them to seek medical attention immediately if they
experience them.
Patients should not stop or change your dose of tofacitinib without first talking to your health care
professional, as doing so may worsen your condition. Patients taking tofacitinib should seek medical
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attention immediately if you experience symptoms of a blood clot in your lungs or other unusual
symptoms such as:
Sudden shortness of breath or difficulty breathing
Chest pain or pain in your back
Coughing up blood
Excessive sweating
Clammy or bluish colored skin
Healthcare professionals and patients are encouraged to report adverse events or side effects related to
the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting
Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to
the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Source: U.S. Food and Drug Administration (FDA)
FDA updates table of interim limits for nitrosamine impurities in ARBs
[Posted 2/28/2019]
FDA is posting the updated table of interim acceptable intake limits for nitrosamine impurities to reflect
N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) limits, which are the same as those for NDMA.
The agency will use the interim limits below to recommend manufacturers conduct a voluntary recall if
laboratory testing confirms the presence of nitrosamine impurities in finished drug product. FDA is
working with industry and international regulators to ensure products entering the market do not
contain these impurities, but we are tolerating the impurities below the level established in the table for
a short period of time to avoid a possible shortage of ARBs.
Not all ARB products contain NDMA, NDEA or NMBA impurities, so pharmacists may be able to provide
an alternative medication not affected by the recalls, or health care professionals may prescribe a
different medication that treats the same condition.
Interim Limits for NDMA, NDEA, and NMBA in Angiotensin II Receptor Blockers (ARBs)
Drug Maximum Daily Dose (mg/day)
Acceptable Intake NDMA (ng/day)*
Acceptable Intake NDMA (ppm)**
Acceptable Intake NDEA
(ng/day)*
Acceptable Intake NDEA
(ppm)**
Acceptable Intake NMBA
(ng/day)*
Acceptable Intake NMBA
(ppm)**
Valsartan 320 96 0.3 26.5 0.083 96 0.3 Losartan 100 96 0.96 26.5 0.27 96 0.96
Irbesartan 300 96 0.32 26.5 0.088 96 0.32 Azilsartan 80 96 1.2 26.5 0.33 96 1.2
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Olmesartan 40 96 2.4 26.5 0.66 96 2.4 Eprosartan 800 96 0.12 26.5 0.033 96 0.12 Candesarta
n 32 96 3.0 26.5 0.83 96 3.0
Telmisartan 80 96 1.2 26.5 0.33 96 1.2
* The acceptable intake is a daily exposure to a compound such as NDMA, NDEA, or NMBA that
approximates a 1:100,000 cancer risk after 70 years exposure
** These values are based on a drug's maximum daily dose as reflected in the drug label
FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and
irbesartan
Torrent again expands its voluntary recall of losartan; Hetero also voluntarily recalls losartan
[Posted 3/1/2019]
Torrent Pharmaceuticals Limited is further expanding its voluntary recall to include 114 additional lots of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets. This recall is due to unacceptable amounts of N-Methylnitrosobutyric acid (NMBA) in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited.
Today, the agency also issued a press release to provide additional information about its ongoing investigation and another voluntary recall by Hetero/Camber Pharmaceuticals, which was announced on February 28, of 87 lots of losartan potassium tablets (25 mg, 50 mg and 100 mg). The recalled losartan potassium and losartan potassium/hydrochlorothiazide tablets are also manufactured by Hetero, which are distributed by Camber, and contain the impurity NMBA.
Torrent and Hetero/Camber are only recalling lots of losartan-containing medication with NMBA above the interim acceptable intake limits of 0.96 parts per million (ppm).
The agency also updated the list of losartan products under recall.
Aurobindo expands its voluntary recall of valsartan and amlodipine/valsartan
[Posted 3/1/2019]
AurobindoPharma USA is expanding its voluntary recall to include 38 additional lots of valsartan and
amlodipine/valsartan combination tablets. The recall is due to unacceptable amounts of N-
Nitrosodiethylamine (NDEA) found in the medicine.
Aurobindo is only recalling lots of valsartan-containing medication where NDEA has been detected
above the interim acceptable intake limit of 0.083 parts per million. FDA is working with manufacturers
to reduce and remove nitrosamines from angiotensin II receptor blockers (ARBs).
The agency also updated the valsartan products under recall.
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Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement
[Posted 3/4/2019]
Weston, Florida, Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany.
Risk Statement : As a result of this packaging error, where a patient does not take a tablet due to a missing tablet or that a patient takes a placebo instead of an active tablet, loss of efficacy is possible due to variation in the dosage consumed. To date, no case has been reported for pregnancy and adverse event to Apotex.
Patients who have received impacted lots of Drospirenone and Ethinyl Estradiol Tablets, USP 3 MG/0.03 MG or have questions regarding this recall please contact your pharmacy. Individuals should not interrupt their therapy, use a non-hormonal method of birth control, contact their health care provider for medical advice and may return the impacted packages to their pharmacist.
Drospirenone and Ethinyl Estradiol Tablets, USP are an estrogen/progestin COC indicated for use by women to prevent pregnancy. Drospirenone and ethinyl estradiol tablets (inner carton) consists of 28 film-coated, biconvex tablets in the following order: 21 yellow color tablets, each containing 3 mg drospirenone (DRSP) and 1.3 mg ethinyl estradiol (EE), and 7 placebo white color tablets. The affected Drospirenone and Ethinyl Estradiol Tablets, USP lots include the following and can be identified by NDC numbers stated on the inner and outer cartons:
NDC number on outer carton
NDC Number on inner carton
Lot Number
Expiration Date
Strength
Configuration/Count
60505-4183-03
60505-4183-01
7DY008A
7DY009A
7DY010A
7DY011A
08/2020
3 MG/
0.03 MG
Outer Carton: Contains three inner Cartons Inner Carton: Contains 1 blister with 21 active yellow color tablets and 7 placebo white color tablets.
The affected Drospirenone and Ethinyl Estradiol Tablets were distributed Nationwide to wholesalers and distributors.
Apotex Corp. has notified its affected wholesalers and distributors via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product. Patients / users that have the affected lots of Drospirenone and Ethinyl Estradiol Tablets, USP which are being recalled should consult with their healthcare provider.
Wholesalers, Distributors and Retailers return the impacted product to place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who
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purchased the impacted product directly from Apotex can call GENCO at 1- 877-674-2082 (7:00am – 5:00pm, CST Monday thru Friday), to arrange for their return.
Consumers with questions regarding this recall can contact Apotex corp. by phone-number 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address [email protected] . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online : www.fda.gov/medwatch/report.htm
Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: U.S. Food and Drug Administration (FDA)
Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to
the Presence of Particulate Matter
[Posted 3/15/2019]
Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV,
NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the
Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confirmed
as glass.
The administration of a glass particulate, if present in an intravenous drug, may result in local irritation
or swelling in response to the foreign material. More serious potential outcomes would include blockage
and clotting in blood vessels, which may be life-threatening if a critical organ is affected. To date,
Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots. The
risk is reduced by the possibility of detection, as the label contains a clear statement directing the
healthcare professional to visually inspect the product for particulate matter and discoloration prior to
administration.
The 8.4% Sodium Bicarbonate Injection, USP, is a sterile, hypertonic solution of sodium bicarbonate
(NaHCO3) in water for administration by the intravenous route. It is indicated for the treatment of
metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, dehydration, severe
diarrhea, circulatory insufficiency due to shock, cardiac arrest and severe lactic acidosis. Sodium
bicarbonate is also indicated for the treatment of certain drug intoxications.
8.4% Sodium Bicarbonate Injection, USP, NDC# 0409-6625-02, is packaged in 50 mL glass fliptop vials in
a case pack of 4 x 25- 50mL. The affected lots and their expiry dates are indicated in the table below.
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Product was distributed Nationwide to Wholesalers/Distributors/Hospitals in the United States and
Puerto Rico from August 2017 to September 2017.
NDC Lot Number Expiration Date Strength Configuration/Count
00409-6625-02 79-238-EV 1JUL2019 50 mEq/50 mL Case Pack 4 x 25, 50 mL
00409-6625-02 79-240-EV 1JUL2019 50 mEq/50 mL Case Pack 4 x 25, 50 mL
00409-6625-02 80-088-EV 1AUG2019 50 mEq/50 mL Case Pack 4 x 25, 50 mL
Hospira, Inc. places the utmost emphasis on patient safety and product quality at every step in the
manufacturing and supply chain process. Hospira, Inc. has notified its direct customers via a recall letter
to arrange for return of any recalled product.
Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine
immediately. Inform Healthcare Professionals in your organization of this recall. For additional
assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through
Friday.
For clinical inquiries, please contact Hospira/Pfizer using the below information.
Contact Contact Information Areas of Support
Pfizer Medical Information 1-800-438-1985, option 3 (8 am to 7 pm Monday through Friday)
Medical inquiries
Pfizer Safety 1-800-438-1985, option 1 (24 hours a day, 7 days per week)
To report adverse events or product complaints
Adverse reactions or quality problems experienced with the use of this product may be reported to the
FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088
to request a reporting form, then complete and return to the address on the pre-addressed form, or
submit by fax to 1-800-FDA-0178.
This recall is being executed with the knowledge of the U.S. Food and Drug Administration.
Source: U.S. Food and Drug Administration (FDA)
Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium
Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl
4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmaceutical Ingredient (API)
[Posted 3/19/2019]
Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg,
50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc.
issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of
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N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an
active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).
NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events
related to this recall.
Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive
heart failure and is packaged in 30ct bottles. The identifying NDC numbers associated with Legacy’s
product are as follows:
Losartan Potassium, USP, 25mg NDC 68645-577-54 Losartan Potassium, USP, 50mg NDC 68645-578-54
Losartan Potassium, USP, 100mg NDC 68645-579-54
The affected Losartan Potassium includes 40 repackaged lots numbers which are listed below:
Legacy NDC# Name and Strength Count Legacy Lot# Expiry
68645-577-54 Losartan Potassium Tablets USP 25 mg 30 180952 10/2019
68645-577-54 Losartan Potassium Tablets USP 25 mg 30 180953 12/2019
68645-577-54 Losartan Potassium Tablets USP 25 mg 30 181086 09/2019
68645-577-54 Losartan Potassium Tablets USP 25 mg 30 181572 01/2020
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 180921 09/2019
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 180922 10/2019
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 180923 11/2019
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 180924 11/2019
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 181118 11/2019
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 181119 10/2019
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 181407 11/2019
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 181408 12/2019
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 181573 02/2020
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 181725 02/2020
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 181726 02/2020
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 181948 03/2020
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 181960 02/2020
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 182385 03/2020
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 182386 03/2020
686645-578-54 Losartan Potassium Tablets USP 50 mg 30 182387 03/2020
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 180886 11/2019
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 180887 12/2019
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 180888 12/2019
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 180905 12/2019
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181123 09/2019
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181124 10/2019
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181125 08/2019
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181351 11/2019
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181352 12/2019
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181551 11/2019
Page 15 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181628 06/2020
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181629 06/2020
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181727 06/2020
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181728 06/2020
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181890 03/2020
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181891 06/2020
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 181897 06/2020
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 182114 03/2020
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 182119 06/2020
68645-579-54 Losartan Potassium Tablets USP 100 mg 30 182120 06/2020
The product can be identified by checking the product name and repackaged lot number on the bottle
containing these products.
Losartan Potassium was distributed by pharmacies nationwide. Legacy Pharmaceutical Packaging LLC is
notifying its distributors and customers in writing and is arranging/assisting for return of all recalled
products to (a) For Distribution Center Level, please return the products to Legacy Pharmaceutical
Packaging LLC; (b) For Retail Level, please return the products to Genco; or (c) For Consumer Level,
please return the products to the dispensing pharmacy, whichever is applicable. Instructions for
returning recalled products are provided in the recall letter.
Consumers with questions regarding this recall can contact your dispensing pharmacy during normal
business hours. Consumers should contact their physician or healthcare provider if they have
experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the
FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then
complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: U.S. Food and Drug Administration (FDA)
Page 16 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
STUDIES AND RECENT TOPICS
Silver health plans set stiffer cost-sharing on drugs than employer plans
March 1, 2019
Two new studies show how health plans are jacking up patients' out-of-pocket costs for prescription
drugs. The studies highlight some of the concerns raised during Tuesday's Senate Finance Committee
hearing featuring the CEOs of seven major pharmaceutical manufacturers.
Source: modernhealthcare.com
Lidose-Isotretinoin Sustains Long-Term Acne Benefit Without Food Intake
March 4, 2019
A new study shows that a twice-daily treatment of lidose-isotretinoin administered without food is
associated with decreased lesions and condition severity in patients with nodular acne.
In new data presented at the American Academy of Dermatology (AAD) 2019 Annual Meeting in
Washington, DC, this week, investigators Andrea Zaenglein, MD, and James Del Rosso, DO, showed that
common acne therapy isotretinoin was associated with significant and sustained improvements to
symptoms and metrics for quality of life (QoL).
Source: mdmag.com
Health Systems Share Their Approaches to Improve Patient Engagement
March 5, 2019
Health systems are actively developing consumer technologies to help patients better manage their
health, and a recent report involving several of these health systems revealed some novel ways to
accomplish this goal.
Using patient-centered health care technologies, these health sytems were able to deliver positive
measurable outcomes for patients, researchers reported in the March issue of Health Affairs.
Source: pharmacytimes.com
Page 17 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
FDA finalizes guidance for compounding bulk substances
March 5, 2019
FDA issued final guidance for outsourcing facilities that make drugs using bulk substances. The guidance,
Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the
Federal Food, Drug, and Cosmetic Act, outlines a framework FDA will use to determine when there is a
clinical need for facilities to make drugs using bulk substances. FDA said the new measures are being set
in place to protect patients.
Source: pharmacist.com
U.S. Cities Skeptical Of FDA Warnings Against Medicine Imports From Canadian Firm
March 6, 2019
Cities and local governments in several states say they will continue to use a Canadian company to offer
employees prescription drugs at a highly reduced price, even though officials from the U.S. Food and
Drug Administration have raised safety concerns about the practice.
Source: npr.org
Patients Experiment With Prescription Drugs To Fight Aging
March 6, 2019
Dr. Alan Green’s patients travel from around the country to his tiny practice in Queens, N.Y., lured by
the prospect of longer lives.
Over the past two years, more than 200 patients have flocked to see Green after learning that two drugs
he prescribes could possibly stave off aging. One 95-year-old was so intent on keeping her appointment
that she asked her son to drive her from Maryland after a snowstorm had closed the schools.
Source: khn.org
Which Misused Prescription Meds Send Americans to the ER?
March 6, 2019
Most folks treated in a U.S. emergency room for misuse of prescription medications get into trouble
because they mix different substances, a new study reports.
Benzodiazepines like Xanax (alprazolam) and Ativan (lorazepam) are most commonly implicated in
health crises that lead to an ER visit, followed by prescription opioids, researchers found.
Page 18 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Source: healthday.com
Nasal spray for depression is promising, but precautions should be taken
March 9, 2019
On Tuesday March 5, the U.S. Food and Drug Administration approved a nasal spray called esketamine,
a molecular variation of ketamine, which can alleviate symptoms of treatment-resistant depression in
just a few hours. While ketamine has attracted criticism and controversy over the years, there are
numerous reasons to celebrate this development, even if it’s with some caution.
Source: thehill.com
Addiction counselor create app to fight drug overdoses
March 9, 2019
Evanston, Ill. (AP) — A former heroin user who is now an addiction counselor in suburban Chicago has
created a smartphone app that aims to prevent drug overdoses.
Lucien Izraylov, 41, has created the Harmredux app, which connects drug users with trained volunteers
who will carry overdose-reversing medication to make sure they survive drug use, The Chicago Tribune
reported. The app is available for iPhones and Androids. Source: apnews.com
Lilly's combo therapy succeeds in late-stage lung cancer study
March 12, 2019
Eli Lilly and Co’s combination cancer treatment met the main goal of a late-stage clinical trial testing it
on patients with a form of lung cancer, the drugmaker announced on Tuesday.
Previously untreated patients with metastatic non-small cell lung cancer taking a combination of Lilly’s
Cyramza and Roche’s erlotinib went longer before their disease started to worsen, study results showed.
Source: reuters.com
Are 'Inactive' Ingredients in Your Drugs Really So Harmless?
March 13, 2019
More than 90 percent of the medications that Americans take contain an inactive ingredient that could
cause an allergic reaction, a new study suggests.
Lactose, peanut oil, gluten and chemical dyes are added to drugs to improve taste, prolong shelf life,
improve absorption or make the drug tamper-proof, researchers explained. But they can also spell
trouble for patients who are allergic to those ingredients.
Source: healthday.com
Page 19 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Antifungal drug could help cystic fibrosis patients for whom common treatments don’t work
March 13, 2019
For one in 10 cystic fibrosis patients, current therapies don’t work, leaving them ravaged by shortness of
breath and bouts of pneumonia and other infections. Now, there hope for them in the form of a
medicine that’s already approved to fight fungal infections, researchers report today. The treatment
appears to restore healthy function in human cells affected by cystic fibrosis as well as in pigs with the
disease.
Source: sciencemag.org
Gottlieb criticizes sponsors’ ‘continued reluctance’ to rethink clinical trials
March 15, 2019
Outgoing FDA Commissioner Scott Gottlieb, M.D., has criticized the “continued reluctance” of sponsors
and CROs to adopt innovative approaches to clinical trials. Gottlieb challenged industry and academia to
invest in new approaches and realign incentives to make clinical research more agile and effective.
Source: fiercebiotech.com
FDA Accepts AR101 BLA for Peanut Allergy
March 19, 2019
The US Food and Drug Administration (FDA) has accepted Aimmune’s Biologics License Application for
AR101. The therapy is seeking approval as a treatment to reduce the risk of anaphylaxis in peanut-
allergic children and adolescents following exposure to peanut.
Source: mdmag.com
Page 20 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
RECALLS
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
Maeng Da Kratom, packaged in a) 25 gram
powder (UPC 00859667007118), b) 50
gram powder (UPC 00859667007125), c) 100
gram powder (UPC 00859667007132), Sunstone Organics
Springfield, Oregon 97473, 541-972-3327.
Class I Lot #124A
MICROBIAL CONTAMINATIO
N OF NON-STERILE
PRODUCTS: Analysis of
samples were positive for Salmonella.
Todd Holiday
dba Sunstone Organics
Drugs
White Vein Kratom, packaged in a) 25 gram
powder (UPC 00859667007316), b) 50
gram powder (UPC 00859667007323), c) 100
gram powder (UPC 00859667007330), Sunstone Organics
Springfield, Oregon 97473, 541-972-3327.
Class I Lot #119
MICROBIAL CONTAMINATIO
N OF NON-STERILE
PRODUCTS: Analysis of
samples were positive for Salmonella.
Todd Holiday
dba Sunstone Organics
Drugs
White Vein Kratom, packaged in a) 20 count
capsules (UPC 00859667007347), b) 60
count capsules (UPC 00859667007354), c) 150
count capsules (UPC 00859667007361), Sunstone Organics
Springfield, Oregon 97473 541-972-3327.
Class I Lot #119
MICROBIAL CONTAMINATIO
N OF NON-STERILE
PRODUCTS: Analysis of
samples were positive for Salmonella.
Todd Holiday
dba Sunstone Organics
Drugs
Maeng Da Kratom, packaged in a) 20 count
capsules (UPC 00859667007149), b) 60
count capsules (UPC 00859667007156), c) 150
count capsules (UPC 00859667007163) , Sunstone Organics
Springfield, Oregon 97473,
Class I Lot #124A
MICROBIAL CONTAMINATIO
N OF NON-STERILE
PRODUCTS: Analysis of
samples were positive for Salmonella.
Todd Holiday
dba Sunstone Organics
Page 21 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
541-972-3327.
Drugs
Dr. King's aquaflora Candida High Potency, 8 fl.
oz. (236 mL), King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806 USA, UPC 35795580018, NDC
57955-8020-89
Class I
Lot Numbers: 120217R Exp.
12/19; 102017C Exp. 10/19;
101017G Exp. 10/19; 111417C
Exp. 11/19; 062818E Exp.
06/20; 122817B Exp. 12/19;
030818B Exp. 03/20; 010716A
Exp. 01/19; 011617H Exp.
01/20; 012517M Exp. 01/20;
020717A Exp. 02/20; 021816A
Exp. 02/19; 031016C Exp.
03/19; 031016D Exp. 03/19;
033016K Exp. 03/19; 052516J
Exp. 05/19; 052918G Exp.
05/20; 062116A Exp. 06/19;
062818A Exp. 06/20; 062818F
Exp. 06/20; 090816B Exp.
06/20; 101216A Exp. 10/19;
112315A Exp. 11/18; 112916C
Exp. 11/19; 120816N Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Lymph Detox, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955506324, NDC
Class I
Lot Numbers: 081815F Exp.
08/18; 030916V Exp. 03/19;
061316B Exp.
Microbial contamination
King Bio Inc.
Page 22 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
57955-5063-2 06/19; 1208016H Exp. 12/19;
010118BE Exp. 01/01/20;
041017M Exp. 04/19
Drugs
Dr. King's Natural Medicine Homeopathic Male Libido, 2 fl. oz. (59
mL), King Bio, Inc. 3 Westside Dr. Asheville, NC
28806, UPC 3579555101022, NDC
57955-5510-2
Class I
Lot Numbers: 030216F Exp.
03/19; 051216K Exp. 05/19;
080315E Exp. 08/2018; 080916Q
Exp. 08/2019; 120816E Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Regional Allergies Northeastern U.S., 2 fl. oz.
(59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955519225, NDC
57955-0753-2
Class I
Lot Numbers: 030817M Exp.
03/19; 050216E Exp. 05/19;
070816D Exp. 07/19; 010118D
Exp. 01/20; 030418B Exp.
03/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Regional Allergies Rocky Mtns. U.S., 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955518624, NDC
57955-0200-2
Class I
Lot Numbers: 0301817L Exp.
03/19; 030916G Exp. 03/19;
052615C Exp. 05/18; 080116B
Exp. 08/19; 091015T Exp.
09/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Cold Sores & Herpes, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955516521, NDC
57955-5165-2
Class I
Lot Numbers: 030218B Exp.
03/20; 033116H Exp. 03/19;
061815J Exp. 06/18; 062716B
Exp. 06/19; 091616C Exp.
09/19; 111017B Exp. 11/19;
123015A Exp. 12/18
Microbial contamination
King Bio Inc.
Page 23 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
Dr. King's Natural Medicine Homeopathic
Menstrual Cramps & Irregularities 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955500421, NDC
57955-5004-02
Class I
Lot Numbers: 041416J Exp.
04/19; 070816F Exp. 07/19;
091015K Exp. 09/2018; 030218C
Exp. 03/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Regional Allergies Pacific U.S. 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806, UPC 357955519324, NDC
57955-8198-2
Class I
Lot Numbers: 030816C Exp.
03/19; 052616C Exp. 05/19;
062215K Exp. 06/18; 012518B
Exp. 01/20; 040218B Exp.
04/20; 050417A Exp. 05/19;
030817P Exp. 03/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Bladder Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955504528, NDC 57955-1503-2
Class I
Lot Numbers: 022616A Exp.
02/19; 030218D Exp. 03/20;
050216AC Exp. 05/19; 072216K
Exp. 07/19; 083115H Exp.
08/18; 120717A Exp. 12/19;
123015C Exp. 12/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Regional Allergies Southern U.S., 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955518426, NDC
57955-0760-2
Class I
Lot Numbers: 022717K Exp.
02/20; 030816D Exp. 03/19;
030817R Exp. 03/19; 061815H
Exp. 06/18; 030418A Exp.
03/20
Microbial contamination
King Bio Inc.
Drugs Dr. King's Natural
Medicine Homeopathic Heart Regularity, 2 fl. oz.
Class I Lot Numbers: 030718F Exp.
03/20; 051716N
Microbial contamination
King Bio Inc.
Page 24 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
(59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955506522, NDC
57955-5065-2
Exp. 05/19; 080916K Exp.
08/19
Drugs
Dr. King's Natural Medicine Homeopathic Heartburn Reliever, 2 fl.
oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955502227, NDC
57955-5022-2
Class I
Lot Numbers: 020817H Exp.
02/20; 030816A Exp. 03/19;
050216B Exp. 05/19; 061616B
Exp. 06/19; 072115C Exp.
07/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Regional Allergies Plains
U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806, UPC 357955518585, NDC
57955-8199-2
Class I
Lot Numbers: 030816B Exp.
03/19; 030817H Exp. 03/19;
092815A Exp. 09/18; 010118C
Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Regional Allergies Desert U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806, UPC 357955518822, NDC
57955-8196-2
Class I
Lot Numbers: 030916Q Exp.
03/19; 052616A Exp. 05/19;
072516J Exp. 07/19; 072815B
Exp. 07/18; 012918A Exp.
01/20; 030817J Exp. 03/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Regional Allergies Great Lakes U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955519027, NDC 57955-8195-2
Class I
Lot Numbers: 030817K Exp.
03/19; 030916H Exp. 03/19;
061615F Exp. 06/18; 071416B
Exp. 07/19; 022618J Exp.
02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Regional Allergies Southwestern U.S., 2 fl.
Class I
Lot Numbers: 010118A Exp.
01/20; 020117B Exp. 02/20;
Microbial contamination
King Bio Inc.
Page 25 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955518921, NDC
57955-8202-2
022717J Exp. 02/20; 030817N
Exp. 03/19; 031417A Exp.
03/20; 041416H Exp. 04/19;
111016C Exp. 11/19; 122915C
Exp. 12/18
Drugs
Dr. King's Natural Medicine Homeopathic Migraine Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955502821, NDC 57955-5028-2
Class I
Lot Numbers: 011617D Exp.
01/20; 030818M Exp. 03/20;
083116B Exp. 08/2019; 101217B
Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Skin Irritations & Itch Relief, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955516828, NDC 57955-5168-2
Class I
Lot Numbers: 010818C Exp.
01/20; 030916S Exp. 08/18;
041117K Exp. 04/19; 072216M
Exp. 07/19; 083115F Exp.
08/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Colds & Flu Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955518228, NDC 57955-6182-2
Class I
Lot Numbers: 010615B Exp.
01/19; 030916U Exp. 03/19;
121117D Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Breakthrough for the Common Cold, 1 fl. oz.
(29.6 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955122111, NDC
57955-1221-1
Class I
Lot Numbers: 031918B Exp.
03/20; 071718Z Exp. 07/20;
071818W Exp. 07/20; 071818X
Exp. 07/20; 071818Y Exp.
07/20; 071818Z Exp. 07/20
Microbial contamination
King Bio Inc.
Drugs Dr. King's Natural Class I Lot Numbers: Microbial King Bio
Page 26 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Medicine Homeopathic Liver Detox, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955006220, NDC
57955-5062-2
012616H Exp. 01/19; 031017C
Exp. 03/20; 052516AB Exp.
05/19; 083115G Exp. 08/18;
083116D Exp. 08/19; 010118R
Exp. 01/20
contamination Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Gallbladder Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955506829, NDC
57955-6058-2
Class I
Lot Numbers: 031017K Exp.
03/20; 040616E Exp. 04/19;
060216F Exp. 06/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Restless Leg Symptom Relief, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955544524, NDC 57955-6235-2
Class I
Lot Numbers: 031218D Exp.
03/20; 042717C Exp. 04/20;
072815A Exp. 07/18; 092216C
Exp. 09/19; 120217E Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Scar Freee, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955508724, NDC
57955-5087-2
Class I
Lot Numbers: 031516B Exp.
03/19; 041817A Exp. 04/20;
050216H Exp. 05/19; 081117B
Exp. 08/19; 091015D Exp.
09/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Constipation Relief, 2 fl.
oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955501923, NDC
57955-5019-2
Class I
Lot Numbers: 031517B Exp.
03/20; 040616G Exp. 04/19;
072716B Exp. 07/19
Microbial contamination
King Bio Inc.
Drugs Dr. King's Natural
Medicine Homeopathic Class I
Lot Numbers: 022117E Exp.
Microbial contamination
King Bio Inc.
Page 27 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Nuts & Seeds Intolerances, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955520528, NDC
57955-5205-2
02/2020; 032216B Exp. 03/19;
072716E Exp. 07/2019
Drugs
Dr. King's Natural Medicine Homeopathic
Shellfish & Seafood Intolerances, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955520122, NDC
57955-0726-2
Class I
Lot Numbers: 032216A Exp.
03/19; 063016L Exp. 06/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Sinus Relief, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955513421, NDC
57955-5134-2
Class I
Lot Numbers: 032217D Exp.
03/20; 033116B Exp. 03/19;
041518F Exp. 04/20; 061715D
Exp. 06/18; 080116C Exp.
08/19; 100417A Exp. 10/19;
121916A Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Ear Relief Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955515722, NDC 57955-0918-2
Class I
Lot Numbers: 032816B Exp.
03/19; 101917B Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Outdoor Air Pollution
Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955540427, NDC 57955-6104-2
Class I
Lot Numbers: 032816D Exp.
03/2019; 071116R Exp. 02/2019
Microbial contamination
King Bio Inc.
Drugs Dr. King's Natural Class I Lot Numbers: Microbial King Bio
Page 28 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Medicine Homeopathic EMF Detox, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955597520, NDC
57955-5975-2
032816E Exp. 03/19; 033116M
Exp. 03/19; 062817A Exp.
06/19
contamination Inc.
Drugs
Dr. King's Natural Medicine Homeopathic 9-1-1 Burnout, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955597926, NDC
57955-5979-2
Class I
Lot Numbers: 032816F Exp.
03/19; 060816C Exp. 03/19;
082916A Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Menopause Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955500629, NDC 57955-6006-2
Class I
Lot Numbers: 033016J Exp.
03/19; 052516T Exp. 05/19;
080916D Exp. 08/2019; 090915B
Exp. 09/18; 110117F Exp.
11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Appetite & Weight with
P.H.A.T., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955515623, NDC 57955-5181-2
Class I
Lot Numbers: 021718D Exp.
02/20; 112317C Exp. 11/19;
012616G Exp. 01/19; 033116A
Exp. 03/19; 052517F Exp.
05/20; 072916D Exp. 07/19;
091415H Exp. 09/18; 091616A
Exp. 09/19; 121916C Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Lungs & Bronchial Relief, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
Class I
Lot Numbers: 021718D Exp.
02/20; 091415H Exp. 09/18;
012616G Exp. 01/19; 033116A
Microbial contamination
King Bio Inc.
Page 29 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
357955505327, NDC 57955-5053-2
Exp. 03/19; 072916D Exp.
07/19; 091616A Exp. 0919;
121916C Exp. 12/19; 052517F
Exp. 05/20; 112317C Exp.
11/19
Drugs
Dr. King's Natural Medicine Homeopathic
Anxiety & Nervousness, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955516323, NDC 57955-5163-2
Class I
Lot Numbers: 033116D Exp.
03/19; 042717D Exp. 04/20;
061616A Exp. 06/19; 072818A
Exp. 07/20; 081015D Exp.
08/18; 091516C Exp. 09/19;
112117F Exp. 11/19; 121516A
Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Advanced Arnica, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955598428, NDC 57955-5984-2
Class I
Lot Numbers: 010518D Exp.
01/20; 033116E Exp. 03/19;
080916H Exp. 08/19; 080917C Exp. 08/2019; 081015C Exp.
08/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Back, Muscle & Joint Relief, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955516125, NDC 57955-6161-2
Class I
Lot Numbers: 012317H Exp.
01/20; 021418A Exp. 02/20;
033116F Exp. 03/19; 072216H
Exp. 07/19; 102717C Exp.
10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Arthritis Pain & Joint Relief, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside
Class I
Lot Numbers: 022417L Exp.
02/20; 033116G Exp. 03/19;
062316C 06/19;
Microbial contamination
King Bio Inc.
Page 30 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Dr. Asheville, NC 28806, UPC 357955516224, NDC
57955-6162-2
080917D Exp. 08/19; 091616B
Exp. 09/19; 112117L Exp.
11/19
Drugs
Dr. King's Natural Medicine Homeopathic Yeast Freee, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955507628, NDC
57955-5076-2
Class I
Lot Numbers: 011518E Exp.
01/20; 033116J Exp. 03/19;
041017C Exp. 04/19; 072216G
Exp. 07/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Urinary Tract Irritations, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955505228, NDC 57955-5062-2
Class I
Lot Numbers: 033116K Exp.
03/19; 060616A Exp. 06/19;
071316L Exp. 07/19; 080315G
Exp. 08/18; 111516D Exp.
11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Animal Hair & Dander
Allergy Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955519621, NDC 57955-6490-2
Class I
Lot Numbers: 012616J Exp.
01/19; 033116L Exp. 03/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Eye Stress, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955515128, NDC 57955-5151-2
Class I
Lot Numbers: 033116P Exp.
03/19; 110916B Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Hangover Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
Class I
Lot Numbers: 033116Q Exp.
03/19; 083115C Exp. 08/18;
111516E Exp. 11/19
Microbial contamination
King Bio Inc.
Page 31 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
357955511328, NDC 57955-5113-2
Drugs
Dr. King's Natural Medicine Homeopathic
Weather Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955528722, NDC 57955-5287-2
Class I
Lot Numbers: 033116R Exp.
03/19; 070816A Exp. 07/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Eggs & Meats Intolerances, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955522027, NDC
57955-0723-2
Class I
Lot Numbers: 033116S Exp.
03/19; 063016M Exp. 06/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Acne Clear, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955504122, NDC
57955-5041-2
Class I
Lot Numbers: 020116C Exp.
02/19; 033117C Exp. 03/20;
050216F Exp. 05/19; 072716D
Exp. 07/19; 091416J Exp.
09/19; 101017D Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Mental Alertness for Seniors, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955595625, NDC 57955-5956-2
Class I
Lot Numbers: 021016K Exp.
02/19; 022317G Exp. 02/2020; 040115C Exp.
04/2018; 062416B Exp. 06/19;
112315D Exp. 11/2018
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Indoor Air Pollution Detox, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955540120, NDC
Class I
Lot Numbers: 050216Q Exp.
05/19; 063016J Exp. 06/19
Microbial contamination
King Bio Inc.
Page 32 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
57955-6001-2
Drugs
Dr. King's Natural Medicine Homeopathic
Anti-Aging & Wrinkles for Women, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955814825, NDC 57955-8148-2
Class I
Lot Numbers: 010518L Exp.
01/20; 020718A Exp. 02/20;
050216R Exp. 05/19; 081815H
Exp. 08/18; 101116C Exp.
10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Hemorrhoid Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955502326, NDC 57955-5023-2
Class I
Lot Numbers: 012317C Exp.
01/20; 052516U Exp. 05/19;
050216S Exp. 05/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic PMS Relief, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955500926, NDC
57955-5009-2
Class I
Lot Numbers: 050216J Exp.
05/19; 080416C Exp. 08/19;
081815K Exp. 08/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Advanced First Aid, 2 fl.
oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955511823, NDC
57955-6000-2
Class I
Lot Numbers: 021516A Exp.
02/19; 050216K Exp. 05/19;
081315Q exp. 08/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Muscle Maximizer, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955513322, NDC 57955-5133-2
Class I
Lot Numbers: 010118AE Exp. 01/20; 050216L Exp. 05/2019; 092216E Exp.
09/2019
Microbial contamination
King Bio Inc.
Drugs Dr. King's Natural
Medicine Homeopathic Asthma Symptom Relief, 2
Class I Lot Numbers: 022117B Exp.
02/20; 042417B
Microbial contamination
King Bio Inc.
Page 33 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806, UPC 357955504429, NDC
57955-6044-2
Exp. 04/20; 050118M Exp.
05/20; 052516X Exp. 05/19;
062215B Exp. 06/18; 091015S
Exp. 09/18; 091416H Exp.
09/19; 101017E Exp. 10/19
Drugs
Dr. King's Natural Medicine Homeopathic
Artery, Cholesterol & BP, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955506423, NDC 57955-5064-2
Class I
Lot Numbers: 050216C Exp.
07/19; 071316K Exp. 05/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Blood & Kidney Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955506126, NDC
57955-5061-2
Class I
Lot Numbers: 010517C Exp.
01/20; 050216D Exp. 05/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Bone Strengthener, 2 fl.
oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955507029, NDC
57955-5070-2
Class I
Lot Numbers: 030118N Exp.
03/20; 042616A Exp. 04/19;
070516B Exp. 07/19; 070815B
Exp. 07/18; 101317H Exp.
10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Dairy Intolerances, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955519829, NDC 57955-6722-2
Class I
Lot Numbers: 042116B Exp.
04/19; 062416A Exp. 06/19
Microbial contamination
King Bio Inc.
Drugs Dr. King's Natural
Medicine Homeopathic Class I
Lot Numbers: 041816A Exp.
Microbial contamination
King Bio Inc.
Page 34 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Hydration, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955024224, NDC 57955-0242-2
04/19; 070816E Exp. 07/19
Drugs
Dr. King's Natural Medicine Homeopathic
Allergy & Hay Fever Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955504320, NDC 57955-5043-2
Class I
Lot Numbers: 051016D Exp.
05/19; 052517D Exp. 05/20;
071316J Exp. 07/19; 082015D
Exp. 0818; 041618A Exp.
04/20; 101017F Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Leg Cramp & Spasm Relief, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955543527, NDC 57955-6035-2
Class I
Lot Numbers: 041518J Exp.
04/20; 050516F Exp. 05/19;
101416A Exp. 10/19; 102816D
Exp. 10/19; 123115D Exp.
12/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Foul Bowel, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955531920, NDC
57955-5319-2
Class I
Lot Numbers: 040616J Exp.
04/19; 080216D Exp. 08/19;
081015S Exp. 08/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Morning Sickness Relief, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955500827, NDC 57955-6008-2
Class I
Lot Numbers: 040616K Exp.
04/2019; 072716J Exp. 07/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Grains & Gluten Intolerances, 2 fl. oz. (59
Class I
Lot Numbers: 012517G Exp.
01/20; 040716A Exp. 04/19;
Microbial contamination
King Bio Inc.
Page 35 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955520429, NDC
57955-0724-2
052516Z Exp. 05/19
Drugs
Dr. King's Natural Medicine Homeopathic
Water Retention, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955507826, NDC 57955-5078-2
Class I
Lot Numbers: 012616K Exp.
01/19; 040616H Exp. 04/19;
073015B Exp. 07/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Breast Inflammations & Discomforts, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955500322, NDC
57955-5003-2
Class I
Lot Numbers: 040616D Exp.
04/19; 081016C Exp. 08/19;
010518K Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Wart Freee, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955505921, NDC
57955-5059-2
Class I
Lot Numbers: 010518F Exp.
01/20; 011416A Exp. 01/19;
072216J Exp. 07/19; 100417B
Exp. 10/19; 123115B Exp.
12/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Varicose Veins, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955506621, NDC 57955-5566-2
Class I
Lot Numbers: 030216E Exp.
03/19; 051716R Exp. 05/19;
073115G Exp. 07/18; 121216B
Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Total Mold Allergy Relief, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
Class I
Lot Numbers: 020916A Exp.
02/19; 080916P Exp. 08/19;
081315M Exp. 08/18
Microbial contamination
King Bio Inc.
Page 36 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
357955519522, NDC 57955-6287-2
Drugs
Dr. King's Natural Medicine Homeopathic
Teeth & Gums Formula, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955507321, NDC 57955-5073-2
Class I
Lot Numbers: 010517E Exp.
01/20; 010518A Exp. 01/20;
022417C Exp. 02/20; 052516H
Exp. 05/19; 091616D Exp.
09/19; 112016A Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Swollen Glands Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955512127, NDC
57955-5121-2
Class I
Lot Numbers: 030216A Exp.
03/19; 100815C Exp. 10/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Stye Relief, 2 fl. oz. (59
mL),King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955512523, NDC
57955-5125-2
Class I
Lot Numbers: 020618F Exp.
02/20; 052516AA Exp. 05/19;
091516E Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Stress Control, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955507925, NDC 57955-5852-2
Class I
Lot Numbers: 012616B Exp.
01/19; 020817E Exp. 02/20;
071818G Exp. 07/20; 111017C
Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Sporting Edge, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955503125, NDC 57955-5031-2
Class I
Lot Numbers: 010118AF Exp.
01/20; 022916D Exp. 02/19
Microbial contamination
King Bio Inc.
Drugs Dr. King's Natural Class I Lots: 010118AH Microbial King Bio
Page 37 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Medicine Homeopathic Sore Throat & Laryngitis, 2
fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806, UPC 357955505822, NDC
57955-5058-2
Exp. 01/20; 020916R Exp.
02/19; 022017B Exp. 02/20;
080415E Exp. 08/18; 090816F
Exp. 09/19
contamination Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955508021, NDC 57955-5080-2
Class I
Lots: 012017C Exp. 01/20; 022618B
Exp. 02/20; 063016A Exp.
06/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Sleep Aid, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955503927, NDC 57955-5839-2
Class I
Lots: 021016E Exp. 02/19; 060118C
Exp. 06/20; 060518A Exp.
06/20; 071318G Exp. 07/20;
080717A Exp. 08/19; 081315N
Exp. 08/18; 111516J Exp.
11/19; 122017A Exp. 12/2019; 122915D Exp.
12/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic ShinglePlex, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 35795551829,
NDC 57955-5518-2
Class I
Lots: 081815L Exp. 08/18; 010118Q
Exp. 01/2020; 050216Z Exp.
05/19; 120616E Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Sciatic Nerve Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955503026, NDC
57955-6030-2
Class I
Lots: 012116B Exp. 01/19; 012317E
Exp. 01/20; 052516S Exp.
05/19; 071315A Exp. 07/18;
071818E Exp. 07/20; 080917B
Exp. 08/19;
Microbial contamination
King Bio Inc.
Page 38 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
091416F Exp. 09/19; 120217A
Exp. 12/19
Drugs
Dr. King's Natural Medicine Homeopathic
Paralixer, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955501626, NDC 57955-5016-2
Class I
Lots: 010118Z Exp. 01/20; 012616D
Exp. 01/2019; 021717B Exp.
0919; 091216E Exp. 09/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
No Sweat Anti-Perspirant, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955508526, NDC 57955-5085-2
Class I Lots: 012616E Exp. 01/2019; 060716B
Exp. 06/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Nausea & Motion Sickness, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955505525, NDC 57955-5055-2
Class I
Lots: 020916P Exp. 02/19; 072216P
Exp. 07/19; 010518P Exp.
01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Multi-Strain Flu Relief, 2 fl. oz. (59 mL), King Bio, Inc. 3 Westside Dr. Asheville, NC
28806, UPC 357955519928, NDC
57955-5194-2
Class I
Lots: 013018A Exp. 01/2020; 020618B
Exp. 02/20; 072716H Exp.
07/19; 120617A Exp. 12/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Mental Calm, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955593027, NDC 57955-5930-2
Class I
Lots: 080916S Exp. 08/19; 021016F
Exp. 02/19; 062215J Exp.
06/18
Microbial contamination
King Bio Inc.
Drugs Dr. King's Natural
Medicine Homeopathic Mental Alertness, 2 fl. oz.
Class I Lots: 021016H
Exp.02/19; 061316A Exp.
Microbial contamination
King Bio Inc.
Page 39 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
(59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955505426, NDC
57955-5954-2
06/2019
Drugs
Dr. King's Natural Medicine Homeopathic
Headache Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955515326, NDC 57955-5153-2
Class I Lots: 020718B Exp. 02/20; 091616M
Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Head Colds Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955528227, NDC 57955-5382-2
Class I
Lots: 030216B Exp. 03/19; 051018A
Exp. 05/20; 091715D Exp.
09/18; 092815C Exp. 09/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Hair & Nails Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955504924, NDC
57955-5049-2
Class I Lots: 030216C Exp.
03/19; 080916G Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Grief & Guilt Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955503828, NDC
57955-5038-2
Class I
Lots: 022417G Exp. 02/20; 052516N
Exp. 05/19; 080416D Exp.
08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Gout Symptom Formula, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955502128, NDC 57955-6021-2
Class I
Lots: 020118D Exp. 02/20; 071415A
Exp. 07/18; 080317C Exp.
08/2019
Microbial contamination
King Bio Inc.
Page 40 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
Dr. King's Natural Medicine Homeopathic Fragrance & Phenolic
Allergy Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955520023, NDC 57955-6136-2
Class I
Lots: 012616F Exp. 01/19; 081315F
Exp. 08/18; 010418L Exp.
01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Food Intolerances, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955072720, NDC 57955-0727-2
Class I
Lots: 011216A Exp. 01/19; 030117Q
Exp. 03/20; 050216T Exp.
05/19; 060716H Exp. 06/19;
093016A Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Food Chemical Intolerances, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955504221, NDC
57955-0728-2
Class I
Lots: 120516A Exp. 12/19; 060316C
Exp. 06/19; 010118S Exp.
01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Fever Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955516026, NDC 57955-5160-2
Class I
Lots: 022417H Exp. 02/20; 030216D
Exp. 03/19; 052616J Exp.
05/19; 092815B Exp. 09/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Female Libido, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955511526, NDC 57955-5515-2
Class I
Lots: 020618E Exp. 02/20; 080916U
Exp. 08/18; 102816C Exp.
10/19
Microbial contamination
King Bio Inc.
Drugs Dr. King's Natural
Medicine Homeopathic Dust Mite & Roach Allergy
Class I Lots: 020917L Exp.
02/20; 051116F Exp. 05/19;
Microbial contamination
King Bio Inc.
Page 41 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955519720, NDC 57955-6497-2
100416A Exp. 10/19
Drugs
Dr. King's Natural Medicine Homeopathic Diarrhea Relief, 2 fl. oz. (59 mL), King Bio, Inc. 3
Westside Dr. Asheville, NC 28806, UPC
357955502029, NDC 57955-5020-2
Class I
Lots: 020916Q Exp. 02/19; 022117C
Exp. 02/20; 072015C Exp.
07/18; 081816D Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Cough Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955516620, NDC 57955-5166-2
Class I Lots: 012516A Exp.
01/19; 090816D Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Cosmetic & Household Detox, 2 fl. oz. (59 mL),
King Bio, Inc. 3 Westside Dr. Asheville, NC 28806,
UPC 357955540328, NDC 57955-6103-2
Class I Lots: 021816B Exp.
02/19; 051216Q Exp. 05/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Climate Adaptation Hot & Humid, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955528524, NDC 57955-0173-2
Class I
Lots: 022916C Exp. 02/19; 062415Y
Exp. 06/18; 071316B Exp.
07/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Climate Adaptation Cold & Dry, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806, UPC 357955528326, NDC
57955-5283-2
Class I Lots: 021216L Exp.
02/19; 062415Z Exp. 06/18
Microbial contamination
King Bio Inc.
Page 42 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
Dr. King's Natural Medicine Homeopathic
ClaustroPlex, 2 fl. oz. (59 mL), King Bio, Inc. 3
Westside Dr. Asheville, NC 28806, UPC
357955503521, NDC 57955-5035-2
Class I Lots: 021016J Exp. 02/19; 063016H
Exp. 06/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Bug Away, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955507727, NDC 57955-5077-2
Class I
Lots: 020116A Exp. 07/19; 050516B
Exp. 05/19; 071116B Exp.
07/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Better Breath, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955880127
Class I Lots: 010118F Exp.
01/20; 051716E Exp. 05/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Athlete's Foot Fighter, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955512929, NDC
57955-5219-2
Class I
Lots: 020116B Exp. 02/19; 110116A
Exp. 02/19; 123016B Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Anti-Aging & Wrinkles for Men, 2 fl. oz. (59 mL), King
Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955814726, NDC 57955-8147-2
Class I Lots: 011916C Exp.
01/19; 072716G Exp. 07/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
CataClenz Eye Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC
Class I
Lots: 050216W Exp. 05/19;
080416B Exp. 08/19; 092216L
Exp. 09/19; 101217A Exp.
Microbial contamination
King Bio Inc.
Page 43 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
357955511229, NDC 57955-5112-2
10/19
Drugs
Dr. King's Natural Medicine Homeopathic
Adrenal Burnout, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955597926, NDC 57955-1434-2
Class I
Lots: 050218E Exp. 05/20; 080317E
Exp. 08/19; 120216A Exp.
12/19; 120217F Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
ChemoClenz, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955507123, NDC 57955-5071-2
Class I Lots: 050516A Exp.
05/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Fears & Phobias, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955515227, NDC 57955-5152-2
Class I Lots: 050916G Exp.
05/19; 120816L Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Dental Plak, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955887027, NDC
57955-1904-2
Class I Lots: 051116E Exp.
05/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Additive & Preservative Detox, 2 fl. oz. (59 mL),
King Bio, Inc. 3 Westside Dr. Asheville, NC 28806,
UPC 357955540526, NDC 57955-6206-2
Class I Lots: 051116G Exp.
05/19; 072816A Exp. 07/19
Microbial contamination
King Bio Inc.
Drugs Dr. King's Natural
Medicine Homeopathic UlcerPlex Detox, 2 fl. oz.
Class I Lots: 051716D Exp.
05/19; 100316H Exp. 10/19
Microbial contamination
King Bio Inc.
Page 44 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
(59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955507420, NDC
57955-5074-2
Drugs
Dr. King's Natural Medicine Homeopathic
Total Body Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955536123, NDC 57955-5361-2
Class I
Lots: 052516L Exp. 05/19; 083115D
Exp. 08/18; 091616Q Exp.
09/19; 110817A Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Ear Ringing, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955527527, NDC
57955-5275-2
Class I Lots: 052516V Exp.
05/19; 052517E Exp. 05/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Snore Control, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955512028, NDC 57955-5120-2
Class I
Lots: 052516Y Exp. 05/19; 060518C
Exp. 06/20; 060917F Exp.
06/19; 070518A Exp. 07/20;
080317C Exp. 08/19; 081015B
Exp. 08/18; 081815G Exp.
08/18; 111516C Exp. 11/19;
112317E Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Fears & Nightmares, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955509929, NDC
57955-5099-2
Class I
Lots: 052616F Exp. 05/19; 063015C
Exp. 06/18; 102816K Exp.
10/19
Microbial contamination
King Bio Inc.
Drugs Dr. King's Natural
Medicine Homeopathic Class I
Lots: 052616G Exp. 05/19; 080315C
Microbial contamination
King Bio Inc.
Page 45 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Indigestion Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955502425, NDC 57955-5024-2
Exp. 08/18; 123016D Exp.
12/19
Drugs
Dr. King's Natural Medicine Homeopathic
Ileocecal Valve Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955509820, NDC
57955-6083-2
Class I
Lots: 060116E Exp. 06/19; 083017F
Exp. 08/19; 101716E Exp.
10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
TMJ/Jaw Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955503224, NDC 57955-5032-2
Class I
Lots: 060216C Exp. 06/19; 070815A
Exp. 07/18; 123016E Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Jet
Lag & Shift Change, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955512622, NDC
57955-5126-2
Class I Lots: 060216D Exp.
06/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Constitutional Enhancer, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955514923, NDC 57955-5149-2
Class I Lots: 060316B Exp.
06/19; 072315B Exp. 07/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Birth Ease, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955500223, NDC
Class I Lots: 060316D Exp.
06/19 Microbial
contamination King Bio
Inc.
Page 46 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
57955-5002-2
Drugs
Dr. King's Natural Medicine Homeopathic
Prostate Symptom Relief, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955501121, NDC 57955-0241-2
Class I Lots: 060616B Exp.
06/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Acid Detox, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955512721, NDC
57955-5227-2
Class I Lots: 060716A Exp.
06/19; 092216H Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Caffeine Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806, UPC
357955540229, NDC 57955-6202-2
Class I Lots: 062415T Exp.
06/18; 092716B Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Climate Adaptation Hot & Dry, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806, UPC 357955528623, NDC
57955-0172-2
Class I Lots: 062415V Exp.
06/18 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Natural Medicine Homeopathic
Water Chemical Detox, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806, UPC
357955540021, NDC 57955-6100-2
Class I Lots: 062816C Exp.
06/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Mood Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3
Class I Lots: 062816D Exp.
06/19 Microbial
contamination King Bio
Inc.
Page 47 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Westside Dr. Asheville, NC 28806, UPC
357955503729, NDC 57955-5037-2
Drugs
Dr. King's Natural Medicine Homeopathic
Climate Adaptation Cold & Damp, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,
UPC 357955528425, NDC 57955-0170-2
Class I Lots: 071316G Exp.
07/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Natural Medicine Homeopathic AddictaPlex, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955508328, NDC
57955-5083-2
Class I Lots: 072516B Exp.
07/19; 081715G Exp. 08/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Odor Freee, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955513025, NDC
57955-5130-2
Class I Lots: 102816H Exp. 10/2019; 123016D
Exp. 12/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Homeopathic Heavy Metal Detox, 2 fl.
oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806, UPC 357955228127, NDC
57955-2281-2
Class I Lots: 121917A Exp.
12/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Kids Teething Homeopathic, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806, UPC 357955501824, NDC
57955-0527-2
Class I
Lots: 020118F Exp. 02/2020; 020717B
Exp. 02/2020; 080317D Exp.
08/2019; 110716C Exp. 11/2019; 111617E Exp.
11/2019
Microbial contamination
King Bio Inc.
Drugs Dr. King's Kids Bed Class I Lots: 101615B Exp. Microbial King Bio
Page 48 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Wetting Homeopathic, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955501220, NDC
57955-0447-2
10/2018; 111717C Exp. 11/2019
contamination Inc.
Drugs
Dr. King's Aquaflora Kids Candida Relief
Homeopathic, 4 fl. oz. (118 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806 USA, UPC 357955332244
Class I
Lots: 011416G Exp. 12/2019; 011917R
Exp. 01/2020; 041518H Exp.
09/2018; 081016E Exp. 08/2019;
092815AA Exp. 09/2018
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Children's
Appetite Enhancer for kids! Homeopathic, 2 fl.
oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806 USA, UPC 357955531821, NDC
57955-5318-2
Class I
Lots: 020117F Exp. 02/2020; 060216E
Exp. 06/2019; 080916B Exp.
08/2019; 092415F Exp. 09/2018
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Baby Colic Relief Homeopathic, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806 USA, UPC 357955515821, NDC
57955-0466-2
Class I Lots: 020118H Exp. 02/2020; 092017A
Exp. 09/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine for kids!
Children's Fever Reliever Homeopathic, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside dr. Asheville, NC
28806 USA, UPC 357955515920, NDC
57955-5159-2
Class I
Lots: 021216H Exp. 02/2019; 052616H
Exp. 05/2019; 102815C Exp.
10/2018; 120816A Exp. 12/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine for kids!
Children's Cough Relief Homeopathic, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside dr. Asheville, NC
Class I
Lots: 021216J Exp. 02/2019; 030916T
Exp. 03/2019; 092815E Exp.
09/2018
Microbial contamination
King Bio Inc.
Page 49 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
28806 USA, UPC 357955514527, NDC
57955-6145-2
Drugs
Dr. King's Natural Medicine for kids! Chicken
Pox Symptom Relief Homeopathic, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside dr. Asheville, NC
28806 USA, UPC 357955602521, NDC
57955-6025-2
Class I Lots: 021216K Exp. 02/2019; 062716D
Exp. 06/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Kids Tummy
Aches Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,
NC 28806 USA, UPC 357955514626, NDC
57955-4060-2
Class I
Lots: 021918B Exp. 02/2020; 050516D
Exp. 05/2019; 072216Q Exp.
07/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine for kids!
Attention & Learning Enhancement
Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside dr. Asheville, NC 28806 USA, UPC
357955501527, NDC 57955-5015-2
Class I
Lots: 050216G Exp. 05/2016; 070816C
Exp. 07/2019; 092617F Exp.
09/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine for kids!
Children's Ear Relief Formula Homeopathic, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955531524, NDC
57955-0416-2
Class I
Lots: 050216P Exp. 05/2019; 072516G
Exp. 07/2019; 112315B Exp.
11/2018
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine for kids! Nosebleed Relief
Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside dr. Asheville, NC
Class I Lots: 050516H Exp. 05/2019; 080916J
Exp. 08/2019
Microbial contamination
King Bio Inc.
Page 50 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
28806 USA, UPC 357955514022, NDC
57955-5140-2
Drugs
Dr. King's Natural Medicine for kids!
Children's Growth & Development
Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside dr. Asheville, NC 28806 USA, UPC
357955514220, NDC 57955-5142-2
Class I Lots: 072516E Exp. 07/2019; 050516E
Exp. 05/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Kids Stress &
Anxiety Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,
NC 28806 USA, UPC 357955042327, NDC
57955-0423-2
Class I Lots: 070516E Exp. 07/2019; 081016G
Exp. 08/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine for kids!
Newborn Tonic Homeopathic, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside dr. Asheville, NC
28806 USA, UPC 357955511427, NDC
57955-5114-2
Class I Lots: 063016K Exp. 06/2019; 112315F
Exp. 11/2018
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Bed Wetting Prevention
Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,
NC 28806 USA, UPC 357955001225, NDC
57955-0012-2
Class I Lots: 102216B Exp.
08/2018 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Attention & Learning
Enhancement Children High Potency
Homeopathic Formula for
Class I
Lots: 032316C Exp. 03/2019; 091216A
Exp. 09/2019; 121617A Exp.
12/2019
Microbial contamination
King Bio Inc.
Page 51 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,
NC 28806 USA, UPC 357955001522, NDC
57955-0015-2
Drugs
Dr. King's SafeCare Rx Lower GI Restoration
Digestion High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,
NC 28806 USA, UPC 357955032021, NDC
57955-0322-2
Class I
Lots: 030916J Exp. 03/19; 072516D
Exp. 07/19; 121717A Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Influenza Multi-Strain Flu Medicine Immune High Potency Homeopathic
Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806
USA, UPC 357955019923, NDC 57955-0298-2
Class I
Lots: 011618A Exp. 01/20; 111617H
Exp. 11/19; 122216A Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Lonely Mind & Body High
Potency Homeopathic Formula for Professional
Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806
USA, UPC 357955200024, NDC 57955-2001-2
Class I Lots: 010518H Exp.
01/20; 040616N Exp. 04/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Colic Relief Children High
Potency Homeopathic Formula for Professional
Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806
USA, UPC 357955015826, NDC 57955-0178-2
Class I Lots: 111717E Exp.
11/19 Microbial
contamination King Bio
Inc.
Drugs Dr. King's SafeCare Rx Class I Lots: 102016J Exp. Microbial King Bio
Page 52 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Children's Appetite & Weight Control Children
High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806 USA, UPC 357955251729, NDC
57955-2518-2
10/19 contamination Inc.
Drugs
Dr. King's SafeCare Rx Tummy Aches Children
High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806 USA, UPC 357955014621, NDC
57955-0146-2
Class I Lots: 022316F Exp.
02/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Children's Growth &
Development Children High Potency
Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,
NC 28806 USA, UPC 357955014225, NDC
57955-0148-2
Class I Lots: 020917A Exp. 02/2020; 062716E
Exp. 06/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Children's Cough Children
High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806 USA, UPC 357955014522, NDC
57955-0145-2
Class I Lots: 091015B Exp. 09/2018; 120616B
Exp. 12/2019
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Newborn Tonic Children
High Potency Homeopathic Formula for
Class I Lots: 110915H Exp.
11/18 Microbial
contamination King Bio
Inc.
Page 53 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,
NC 28806 USA, UPC 357955011422, NDC
57955-0114-2
Drugs
Dr. King's SafeCare Rx Children's Ear Relief
Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806 USA, UPC 357955075721, NDC
57955-0758-2
Class I Lots: 032316B Exp.
03/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Chicken Pox Symptom
Relief Children High Potency Homeopathic
Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806
USA, UPC 357955782520, NDC 57955-7825-2
Class I Lots: 042616D Exp.
04/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Children's Fever Reliever
Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806 USA, UPC 357955015925, NDC
57955-0176-2
Class I Lots: 082516A Exp. 08/2019; 102015F
Exp. 10/2018
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Teething Children High Potency Homeopathic
Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806
USA, UPC 357955001829, NDC 57955-0018-2
Class I Lots: 032216C Exp.
03/19 Microbial
contamination King Bio
Inc.
Page 54 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
Dr. King's SafeCare Rx Children's Appetite
Enhancer Children High Potency Homeopathic
Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806
USA, UPC 357955031826, NDC 57955-0318-2
Class I Lots: 022316G Exp.
02/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Natural Medicine Warming
Arthritic Pain & Joint Relief Homeopathic
Cream, Net Wt. 3 oz. (85 g), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806 USA, UPC
357955093534, NDC 57955-0935-3
Class I
Lots: 020318ZZ Exp. 02/20;
051418ZZ Exp. 05/20; 060118ZZ
Exp. 06/20; 020418ZZ Exp.
02/20; 020518ZZ Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Rosacea
Symptom Relief Homeopathic Topical
Lotion, 3 oz. (85 g), King Bio, Inc., 3 Westside dr.
Asheville, NC 28806 USA, UPC 357955091936, NDC
57955-0919-3
Class I
Lots: 021117ZZ Exp. 02/19;
031918ZZ Exp. 03/20; 110217ZZ
Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Psoriasis
Symptom Relief Homeopathic Topical
Lotion, 3 oz. (85 g), King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806 USA, UPC 357955092032, NDC
57955-0920-3
Class I
Lots: 013018ZZ Exp. 01/20;
021217ZZ Exp. 02/19; 110717ZZ
Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Eczema Symptom Relief
Homeopathic Topical Lotion, 3 oz. (85 g), King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806 USA,
Class I
Lots: 010918ZZ Exp. 01/20;
021317ZZ Exp. 02/19; 090717ZZ
Exp. 09/19
Microbial contamination
King Bio Inc.
Page 55 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
UPC 357955092131, NDC 57955-0921-3
Drugs
Dr. King's Natural Medicine Cooling Acute
Pain Relief Pure Homeopathic Cream, 3 oz.
(85 g), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806 USA, UPC 357955400134, NDC
57955-4001-3
Class I
Lots: 060816 Exp. 06/19; 081717ZZ
Exp. 08/19; 110117ZZ Exp.
11/20; 045017ZZ Exp. 04/20;
100516ZZ Exp. 06/19; 111016ZZ
Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Soothing Advanced Arnica Pure Homeopathic Cream
High Potency Homeopathic Formula for Professional Use Only, 3
oz. (85 g), King Bio, Inc., 3 Westside Drive Asheville,
NC 28806 USA, UPC 357955730132, NDC
57955-7301-3
Class I
Lots: 010517ZZ Exp. 01/20;
030818ZZ Exp. 03/21; 040617ZZ
Exp. 04/20; 100616ZZ Exp.
05/19; 110916ZZ Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Upper GI Restoration
Digestion High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive Asheville, NC 28806 USA, UPC 357955032120, NDC
57955-0325-2
Class I
Lots: 051716U Exp. 05/19; 073115C
Exp. 07/18; 080216C Exp.
08/19; 120217N Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Soothing
Advanced Arnica Pure Homeopathic Cream, 3 oz.
(85 g), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955400035, NDC
57955-4000-3
Class I
Lots: 052616 Exp. 05/19; 073118ZZ
Exp. 07/21; 040117ZZ Exp.
06/19; 122717ZZ Exp. 12/20;
040417ZZ Exp. 04/20; 091617ZZ
Exp. 09/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies Plains U.S., 2 fl.
oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Class I Lots: 010118E Exp. 01/20; 011917M
Exp. 01/20
Microbial contamination
King Bio Inc.
Page 56 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Asheville, NC 28806 USA, UPC 357955260226, NDC
57955-2720-2
Drugs
Dr. King's SafeCare Rx CS-Uterus Cancer Support, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955022121, NDC
57955-0247-2
Class I Lots: 092216D Exp.
09/19; 010118H Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies Southern U.S.
Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955260127,
NDC 57955-2721-2
Class I
Lots: 050216AA Exp. 05/19;
101116B Exp. 10/19; 010118K
Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Wart Freee..., 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955005926, NDC
57955-0360-2
Class I
Lots: 060816B Exp. 06/19; 012017D
Exp. 01/20; 010118N Exp.
01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Sugar Metabolizer
Men/Women, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955007227, NDC
57955-0365-2
Class I
Lots: 091015J Exp. 09/18; 060216A
Exp. 06/19; 091216H Exp.
09/19; 010118X Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Lymph Detox Cleansing &
Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 35795506329,
NDC 57955-0339-2
Class I
Lots: 080315A Exp. 08/18; 030916K
Exp. 03/19; 080916T Exp.
08/19; 020817G Exp. 02/20;
010118V Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Intense Anxiety Mind & Body, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806
Class I
Lots: 073015A Exp. 07/18; 123115F
Exp. 12/18; 060916A Exp.
06/19; 042717A
Microbial contamination
King Bio Inc.
Page 57 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
USA, UPC 357955175025, NDC 57955-1751-2
Exp. 04/20; 010118Y Exp.
01/20
Drugs
Dr. King's SafeCare Rx Allergies Southwest U.S., 2
fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955175025, NDC
57955-2715-2
Class I
Lots: 030818A Exp. 03/20; 011416B
Exp. 01/19; 111016B Exp.
11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Skin Irritations & Itch Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955175025, NDC
57955-0177-2
Class I
Lots: 080916V Exp. 08/19; 010418C
Exp. 01/20; 022616G Exp.
02/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx UlcerPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955175025,
NDC 57955-0188-2
Class I Lot: 010418D Exp.
01/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Stye Freee..., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955012528,
NDC 57955-0132-2
Class I
Lots: 083115B Exp. 08/18; 061716A
Exp. 06/19; 120516B Exp.
12/19; 010418F Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Fever Reliever Immune, 2
fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955016021, NDC
57955-0272-2
Class I Lot: 010518J Exp.
01/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Colds & Flu Immune, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955038221, NDC
57955-0382-2
Class I
Lots: 063015F Exp. 06/18; 010616A
Exp. 01/19; 122216B Exp.
12/19; 022417J Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs Dr. King's SafeCare Rx Stress Control Mind &
Class I Lots: 072115A Exp.
07/18; 010616C Microbial
contamination King Bio
Inc.
Page 58 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955185024,
NDC 57955-1852-2
Exp. 01/19; 021216G Exp.
02/19; 072516C Exp. 07/19;
101817A Exp. 10/19; 030818H
Exp. 03/20
Drugs
Dr. King's SafeCare Rx Anti-Aging & Wrinkles For Women, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955614722,
NDC 57955-6148-2
Class I Lots: 032316A Exp.
03/19; 010617B Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx ICV Clenz Cleansing & Detox, 2
fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955009825, NDC
57955-0262-2
Class I
Lots: 081015G Exp. 08/18; 030916B
Exp. 03/19; 012317B Exp.
01/20; 010818A Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Blood & Kidney Detox
Cleansing & Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955006121, NDC
57955-0190-2
Class I Lots: 071116A Exp.
07/19; 010818B Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies: Shellfish &
Seafood Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955220121, NDC
57955-2201-2
Class I Lots: 080315H Exp.
08/18; 010918H Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx M3 Metabolic Mineral
Modulator, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955027621, NDC
57955-0277-2
Class I
Lots: 022216B Exp. 02/19; 062216S
Exp. 06/19; 011217B Exp.
01/20
Microbial contamination
King Bio Inc.
Page 59 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
Dr. King's SafeCare Rx GallPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955006824,
NDC 57955-0340-2
Class I Lots: 110916A Exp.
11/19; 011518B Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Back, Neck, Muscle & Joint
Injuries, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955016120,
NDC 57955-0261-2
Class I
Lots: 011518C Exp. 01/20; 081815J
Exp. 08/18; 032216F Exp.
03/19; 091616P Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies: Dust Mite &
Roach Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955219729, NDC
57955-2197-2
Class I Lots: 062816G Exp.
06/19; 011617B Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Head Colds Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955028222, NDC
57955-0282-2
Class I Lot: 011817B Exp.
01/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx SciatiPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955003021,
NDC 57955-0030-2
Class I Lots: 011817D Exp.
01/20; 080315D Exp. 08/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Indecision Mind & Body, 2
fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955277026, NDC
57955-2771-2
Class I Lot: 011917L Exp.
01/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Aversion to Change Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Class I
Lots: 072015H Exp. 07/18; 111016F
Exp. 11/19; 011917N Exp.
Microbial contamination
King Bio Inc.
Page 60 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drive, Asheville, NC 28806 USA, UPC 357955280026,
NDC 57955-2800-2
01/20
Drugs
Dr. King's SafeCare Rx Wounds Recovery, 2 fl. oz.
(59 mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955011828, NDC
57955-0118-2
Class I
Lots: 081815M Exp. 08/18;
012017B Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Asthma Clear Allergy, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955004424, NDC
57955-0044-2
Class I Lots: 012116S Exp.
01/19; 122116A Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx ScarCure, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955008729,
NDC 57955-0087-2
Class I Lot: 012317A Exp.
01/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Paranoid Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955226024, NDC
57955-2261-2
Class I Lots: 040616B Exp.
04/19; 012317D Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Aversion to Exertion Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955279020,
NDC 57955-2790-2
Class I Lots: 063015F Exp.
06/18; 012517F Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx SYP Miasm Constitution, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955030324, NDC
57955-0306-2
Class I Lots: 012517H Exp.
01/20; 081015N Exp. 08/18
Microbial contamination
King Bio Inc.
Drugs Dr. King's SafeCare Rx Class I Lots: 012517J Exp. Microbial King Bio
Page 61 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Anti-Aging & Wrinkles For Men, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955714729, NDC
57955-7148-2
01/20; 021616D Exp. 02/19;
051716V Exp. 05/19
contamination Inc.
Drugs
Dr. King's SafeCare Rx Repressed Sexual Issues
Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955126027, NDC
57955-1261-2
Class I Lots: 061716B Exp.
06/19; 012517K Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx TUBR Miasm, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955030423, NDC
57955-0304-2
Class I
Lots: 081815N Exp. 08/18; 080116D
Exp. 08/19; 012517L Exp.
01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies Animal Hair & Dander Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955219620, NDC
57955-2196-2
Class I Lot: 020117G Exp.
02/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Migraine Freee..., 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955002826, NDC
57955-0028-2
Class I Lot: 020117H Exp.
02/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Sleep Aid, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955263920,
NDC 57955-2640-2
Class I
Lots: 022318F Exp. 02/20; 020416A
Exp. 02/19; 080916N Exp.
08/19
Microbial contamination
King Bio Inc.
Drugs Dr. King's SafeCare Rx
Acute Viro Reliever, 2 fl. oz. (59 mL), King Bio, Inc.,
Class I Lots: 101617D Exp.
10/19; 072815F Exp. 07/18;
Microbial contamination
King Bio Inc.
Page 62 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955008125, NDC
57955-0432-2
031016L Exp. 03/19; 020618A
Exp. 02/20
Drugs
Dr. King's SafeCare Rx LymePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955006923,
NDC 57955-0069-2
Class I
Lots: 072815F Exp. 07/18; 061716C
Exp. 06/19; 020817D Exp.
02/20; 030518F Exp. 03/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Better Breath Oral Health, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955630128, NDC
57955-6302-2
Class I Lots: 060116G Exp.
06/19; 020817F Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergy/Hay Fever Reliever
Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955004325,
NDC 57955-0043-2
Class I
Lots: 052616F Exp. 05/19; 020917B
Exp. 02/20; 030718D Exp.
03/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx TMJ/Jaw Formula Oral
Health, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955003229,
NDC 57955-0032-2
Class I Lots: 072815H Exp.
07/18; 020917C Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Breast Cyst & Discomforts, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955000327, NDC
57955-0003-2
Class I Lots: 091515A Exp.
09/18; 010517B Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Heart Regularity
Circulation, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955006527, NDC
Class I
Lots: 083115F Exp. 08/18; 091516D
Exp. 09/19; 020917K Exp.
02/20
Microbial contamination
King Bio Inc.
Page 63 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
57955-0065-2
Drugs
Dr. King's SafeCare Rx ShinglePlex Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955750123, NDC
57955-7501-2
Class I
Lots: 070815J Exp. 07/18; 091015G
Exp. 09/18; 021216F Exp.
02/19; 052616M Exp. 05/19;
083016A Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Snore Control Sleep, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955012023, NDC
57955-0120-2
Class I Lots: 021616B Exp.
02/19; 083016B Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Alcoholism Mind & Body, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955302025, NDC
57955-3021-2
Class I Lot: 021217A Exp.
02/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Fears & Nightmares Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955181026,
NDC 57955-1811-2
Class I Lots: 071116C Exp.
07/19; 022017C Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Cold Sores & Herpes Skin, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955016526, NDC
57955-0165-2
Class I
Lots: 032216D Exp. 03/19; 072815G
Exp. 07/18; 022017A Exp.
02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Sexual Identity Mind & Body, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955127024,
NDC 57955-1271-2
Class I Lot: 021717C Exp.
02/20 Microbial
contamination King Bio
Inc.
Drugs Dr. King's SafeCare Rx Class I Lots: 080916F Exp. Microbial King Bio
Page 64 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Male Strengthener, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955001027, NDC
57955-0010-2
08/19; 062215C Exp. 06/18;
021616F Exp. 02/19
contamination Inc.
Drugs
Dr. King's SafeCare Rx Sluggish Mind Mind & Body, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955152026,
NDC 57955-1521-2
Class I Lots: 021616F Exp.
02/19; 111416A Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Adrenal Burnout Mind &
Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955097921,
NDC 57955-0981-2
Class I
Lots: 021616C Exp. 02/19; 0711116P
Exp. 07/19; 102816J Exp.
10/19; 030117N Exp. 03/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Constitutional Enhancer Constitution, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955014928, NDC
57955-0149-2
Class I
Lots: 102016F Exp. 10/19; 022316D
Exp. 02/19; 061716D Exp.
06/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Bone Strengthener, 2 fl.
oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955007029, NDC
57955-0070-2
Class I
Lots: 060316F Exp. 06/19; 022316B
Exp. 02/19; 122216H Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Environmental Adaptation
Cold/Damp, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955028420, NDC
57955-0284-2
Class I Lots: 022316A Exp.
02/19; 031517A Exp. 03/20
Microbial contamination
King Bio Inc.
Drugs Dr. King's SafeCare Rx
Total Body Detox Class I
Lots: 022117K Exp. 02/20; 120316F
Microbial contamination
King Bio Inc.
Page 65 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Cleansing & Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955036128, NDC
57955-0361-2
Exp. 12/19; 040117B
Drugs
Dr. King's SafeCare Rx Chagrined, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955204022, NDC
57955-2041-2
Class I Lots: 060616D Exp.
06/19; 022117H Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Bladder Formula Urinary, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955004523, NDC
57955-0094-2
Class I
Lots: 072815K Exp. 07/18; 080916F
Exp. 08/19; 022117F Exp.
02/20; 052616P Exp. 05/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies Great Lakes U.S., 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955260622, NDC
57955-2713-2
Class I
Lots: 060716F Exp. 06/19; 092216K
Exp. 09/19; 022018D Exp.
02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Headache Freee... U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955015321 NDC
57955-0153-2
Class I
Lots: 022516D Exp. 02/19; 080916A
Exp. 08/19; 121317K Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx TremorPlex U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955003328, NDC
57955-0033-2
Class I
Lots: 022516C Exp. 02/19; 072916F
Exp. 07/19; 030117C Exp.
03/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Chronic Viro Reliever U.S., 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Drive,
Class I
Lots: 080916C Exp. 08/19; 022618A
Exp. 02/20; 072115F Exp.
Microbial contamination
King Bio Inc.
Page 66 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Asheville, NC 28806 USA, UPC 357955008828, NDC
57955-0103-2
07/18; 022516B Exp. 02/19;
052616N Exp. 05/19
Drugs
Dr. King's SafeCare Rx Aller-Detox: Water
Chemicals U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955340027, NDC
57955-3400-2
Class I Lot: 022516A Exp.
02/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Yeast Freee..., 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955007623, NDC
57955-0102-2
Class I Lots: 081116A Exp.
08/19; 022417B Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies: Mold, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955650126, NDC
57955-6501-2
Class I
Lots: 072015D Exp. 07/18; 022317F
Exp. 02/20; 123015B Exp.
12/18; 062816B Exp. 06/19;
091616B Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Arthritis & Joint Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955016229, NDC
57955-0162-2
Class I
Lots: 091015M Exp. 09/18;
022317D Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx ParaClenz, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955001621, NDC
57955-0193-2
Class I
Lots: 081015J Exp. 08/18; 062816A
Exp. 06/19; 101716B Exp.
10/19; 030718A Exp. 03/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Nosebleed Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville,
Class I Lots: 051716K Exp.
05/19; 030317A Exp. 03/20
Microbial contamination
King Bio Inc.
Page 67 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
NC 28806 USA, UPC 357955014027, NDC
57955-0140-2
Drugs
Dr. King's SafeCare Rx Candida, 8 fl. oz. (236 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955620686,
NDC 57955-6207-8
Class I
Lots: 050216AB Exp. 05/19;
071416A Exp. 07/19; 101716C
Exp. 10/19; 030117F Exp.
03/20; 120217C Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx PMS Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955000921, NDC
57955-0095-2
Class I Lots: 082316A Exp.
08/19; 022916E Exp. 02/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx CS-Rectal Bowel, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955021827, NDC
57955-0218-2
Class I
Lots: 022616F Exp. 02/19; 080217A
Exp. 08/19; 060716K Exp.
06/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx CS-Brain, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021223,
NDC 57955-0222-2
Class I Lots: 022616C Exp.
02/19; 122216E Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx CS-Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021926, NDC
57955-0224-2
Class I Lots: 120715B Exp.
12/18; 022616B Exp. 02/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx CS-Bone, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021124,
NDC 57955-0211-2
Class I Lot: 011617C Exp.
01/20 Microbial
contamination King Bio
Inc.
Drugs Dr. King's SafeCare Rx CS-Breast, 2 fl. oz. (59 mL),
Class I Lots: 091515A Exp.
09/18; 010517B Microbial
contamination King Bio
Inc.
Page 68 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021421,
NDC 57955-0214-2
Exp. 01/20
Drugs
Dr. King's SafeCare Rx Sore Throat & Laryngitis, 2
fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955005827, NDC
57955-0137-2
Class I
Lots: 072815M Exp. 07/18;
031016K Exp. 03/19; 030718H
Exp. 03/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Hypochondria, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955180029, NDC
57955-1807-2
Class I Lots: 031016H Exp.
03/19; 103116A Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Self-Pity, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955253020, NDC
57955-2532-2
Class I Lots: 031016G Exp.
03/19; 081916B Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Gossipy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955225027,
NDC 57955-2251-2
Class I Lot: 031016F Exp.
03/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Good Mood Enhancer, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955208020, NDC
57955-2080-2
Class I
Lots: 050317A Exp. 05/20; 072815S
Exp. 07/18; 031016F Exp.
03/19; 071116G Exp. 07/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Urinary Tract Infections, 2
fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955005223, NDC
57955-0052-2
Class I
Lots: 072815J Exp. 07/18; 030916Y
Exp. 03/19; 110716B Exp.
11/19; 101317J Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs Dr. King's SafeCare Rx Class I Lots: 030916N Exp. Microbial King Bio
Page 69 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Aller-Detox: Food Addititives &
Preservatives, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955240525, NDC
57955-2405-2
03/19; 121217A Exp. 12/19
contamination Inc.
Drugs
Dr. King's SafeCare Rx CA Miasm, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955030027,
NDC 57955-0300-2
Class I Lots: 033016H Exp.
03/19; 121216D Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Fear & Phobia, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC
357955179023,NDC 57955-1791-2
Class I
Lots: 072015E Exp. 07/18; 032216G
Exp. 03/19; 102816E Exp.
10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Gout Symptom Relief, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955002123, NDC
57955-0021-2
Class I Lots: 091216G Exp.
09/19; 032216F Exp. 03/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Heavy Metal Detox, 2 fl.
oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955028123, NDC
57955-0281-2
Class I
Lots: 090816H Exp. 09/19; 072815D
Exp. 07/18; 031017J Exp.
03/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Perfectionism, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, NDC UPC
357955184027, NDC 57955-1841-2
Class I Lots: 042717F Exp.
04/20; 031016J Exp. 03/19
Microbial contamination
King Bio Inc.
Drugs Dr. King's SafeCare Rx
Eating Disorders, 2 fl. oz. (59 mL), King Bio, Inc., 3
Class I Lot: 040606L Exp.
04/19 Microbial
contamination King Bio
Inc.
Page 70 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Westside Drive, Asheville, NC 28806 USA, UPC 357955000129, NDC
57955-0001-2
Drugs
Dr. King's SafeCare Rx Easily Angered, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955102021, NDC
57955-1021-2
Class I Lot: 041217C Exp.
04/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Constipation Relief, 2 fl.
oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955001928, NDC
57955-0019-2
Class I
Lots: 072815L Exp. 07/18; 041416L
Exp. 04/19; 082916B Exp.
08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Artery/Cholesterol/BP, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955006428, NDC
57955-0064-2
Class I Lots: 092915G Exp.
09/18; 041416F Exp. 04/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Heartburn Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955002222, NDC
57955-0022-2
Class I Lots: 041416B Exp.
04/19; 091416K Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Bactero Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955011729, NDC
57955-0117-2
Class I
Lots: 092915F Exp. 09/18; 081616B
Exp. 08/19; 041416A Exp.
04/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Envious, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955252023,
NDC 57955-2523-2
Class I Lot: 041217D Exp.
04/20 Microbial
contamination King Bio
Inc.
Page 71 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
Dr. King's SafeCare Rx Extravagant, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955233022, NDC
57955-2331-2
Class I Lot: 040616O Exp.
04/19 Microbial
contamination King Bio
Inc.
Drugs
SafeCareRx Nostalgia, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
NC 28806 USA, UPC 357955278023, NDC
57955-2781-2
Class I Lot: 040616M Exp.
04/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Grief, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955206026,
NDC 57955-2061-2
Class I
Lots: 062415M Exp. 06/18;
040616P Exp. 04/19; 102016K
Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies Desert U.S., 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955260424, NDC
57955-2704-2
Class I Lots: 040118C Exp.
04/20; 031417B Exp. 03/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Appetite & Weight with
P.H.A.T., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955218128,
NDC 57955-2181-2
Class I
Lots: 072915A Exp. 07/18; 121217B
Exp. 12/19; 071116Q Exp.
07/19; 102816F Exp. 10/19;
033117B Exp. 03/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Expressed Sexual Issues, 2
fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955125020, NDC
57955-1257-2
Class I Lot: 051216M Exp.
05/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Bug Away, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806
Class I
Lots: 072215C Exp. 07/18; 070516C
Exp. 07/19; 050516C Exp.
Microbial contamination
King Bio Inc.
Page 72 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
USA, UPC 357955007722, NDC 57955-0077-2
05/19
Drugs
Dr. King's SafeCare Rx Mood Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955202028, NDC
57955-2021-2
Class I Lots: 051216N Exp.
05/19; 120816M Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Indigestion Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955002420, NDC
57955-0024-2
Class I Lot: 041416M Exp.
04/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx VeinoPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955006626, NDC
57955-0066-2
Class I
Lots: 062415H Exp. 06/18; 111516P
Exp. 11/19; 062016D Exp.
06/19; 040717D Exp. 04/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Advanced Arnica, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955730323, NDC
57955-7304-2
Class I
Lots: 040118A Exp. 04/20; 060616C
Exp. 06/19; 110117F Exp.
11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Lungs & Bronchial Relief, 2
fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955005322, NDC
57955-0053-2
Class I
Lots: 070816B Exp. 07/19; 080917A
Exp. 08/19; 050216N Exp.
05/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Insecurity, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955256021, NDC
57955-2561-2
Class I Lots: 042116A Exp.
04/19; 072216N Exp. 07/19
Microbial contamination
King Bio Inc.
Drugs Dr. King's SafeCare Rx Class I Lots: 102116A Exp. Microbial King Bio
Page 73 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Cough Control, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955016625, NDC
57955-0166-2
10/19; 063015D Exp. 06/18;
123115E Exp. 12/18; 051716L
Exp. 05/19; 022117L Exp.
02/20
contamination Inc.
Drugs
Dr. King's SafeCare Rx Leg Cramps & Spasms, 2 fl. oz.
(59 mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955043522, NDC
57955-0435-2
Class I
Lots: 072015J Exp. 07/18; 051716H
Exp. 05/19; 081016B Exp.
08/19; 092617B Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies Northest U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955260721, NDC
57955-2707-2
Class I
Lots: 051716G Exp. 05/19; 072516H
Exp. 07/19; 081117C Exp.
08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Personality Changes, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955105022, NDC
57955-1053-2
Class I Lot: 051716F Exp.
05/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Reserved, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955228028,
NDC 57955-2282-2
Class I Lot: 051216P Exp.
05/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Dental Plak, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955008620, NDC
57955-0086-2
Class I Lots: 051116C Exp.
05/19; 110916C Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx VaccinoClenz, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
Class I
Lots: 081015F Exp. 08/18; 050216Y
Exp. 05/19; 090116C Exp.
Microbial contamination
King Bio Inc.
Page 74 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
NC 28806 USA, UPC 357955003224, NDC
57955-0082-2
09/19
Drugs
Dr. King's SafeCare Rx Calcium Metabolizer, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955013129, NDC
57955-0131-2
Class I
Lots: 071316F Exp. 07/19; 120816B
Exp. 12/19; 050216AD Exp.
05/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies: Grains & Gluten, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955220329, NDC
57955-2203-2
Class I Lots: 112916B Exp.
11/19; 041416E Exp. 04/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Immature, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955229025, NDC
57955-2291-2
Class I Lot: 060716J Exp.
06/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Morning Sickness, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955000822, NDC
57955-0008-2
Class I Lot: 061616F Exp.
06/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Eye Stress, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955015123,
NDC 57955-0151-2
Class I Lots: 060616E Exp.
06/19; 121317F Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Obsessions/Compulsions, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955183020, NDC
57955-1831-2
Class I Lots: 060116F Exp.
06/19; 020917F Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs Dr. King's SafeCare Rx Class I Lot: 052616/f Exp. Microbial King Bio
Page 75 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Complaining, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955230021, NDC
57955-2301-2
05/19 contamination Inc.
Drugs
Dr. King's SafeCare Rx Menstrual Cramps &
Irregularities, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955000426, NDC
57955-0004-2
Class I Lots: 083116E Exp.
08/19; 052616D Exp. 05/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Bio Reset/Jet Lag, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955012627, NDC
57955-0126-2
Class I
Lots: 022316C Exp. 02/19; 052516Q
Exp. 05/19; 102016E Exp.
10/19; 112117G Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Hemorrhoid Relief, 2 fl. oz.
(59 mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955002321, NDC
57955-0023-2
Class I Lots: 052516P Exp.
05/19; 091316B Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Spaced Out, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955154020, NDC
57955-1541-2
Class I Lots: 052516E Exp.
05/19; 121317E Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Restless Leg Syndrome, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955044529, NDC
57955-0445-2
Class I Lots: 051716X Exp.
05/19; 101116A Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs Dr. King's SafeCare Rx
Female Enhancer, 2 fl. oz. (59 mL), King Bio, Inc., 3
Class I Lots: 060316A Exp.
06/19; 120116A Exp. 12/19
Microbial contamination
King Bio Inc.
Page 76 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Westside Drive, Asheville, NC 28806 USA, UPC 357955011521, NDC
57955-0115-2
Drugs
Dr. King's SafeCare Rx Aller-Detox: Herbicides &
Pesticides, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955240624, NDC
57955-2406-2
Class I Lots: 072115D Exp.
07/18; 060216B Exp. 06/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies: Dairy, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955219828, NDC
57955-2198-2
Class I
Lots: 073115B Exp. 07/18; 062116B
Exp. 06/19; 121216C Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies: Nuts & Seeds, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955220428, NDC
57955-2204-2
Class I
Lots: 082815A Exp. 08/18; 112117D
Exp. 11/19; 061416A Exp.
06/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies: Food Chemicals U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955004226, NDC
57955-0042-2
Class I
Lots: 062415X Exp. 06/18; 052815G
Exp. 05/18; 051716T Exp.
05/19; 092216J Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Odor Freee..., 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955013020, NDC
57955-0130-2
Class I Lots: 052516G Exp.
05/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Acid Clenz, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955012726,
Class I Lots: 050216U Exp.
05/19; 072716C Exp. 07/19
Microbial contamination
King Bio Inc.
Page 77 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
NDC 57955-0127-2
Drugs
Dr. King's SafeCare Rx Calloused, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955231028,
NDC 57955-2311-2
Class I Lot: 063016C Exp.
06/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Religious Issues, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955254027, NDC
57955-2541-2
Class I Lot: 063016B Exp.
06/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Hair & Nails Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955004929, NDC
57955-0049-2
Class I
Lots: 072015F Exp. 07/18; 062816E
Exp. 06/19; 100316E Exp.
10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx CS-General Support, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955021322, NDC
57955-0213-2
Class I
Lots: 062716A Exp. 06/19; 091616H
Exp. 09/19; 122217M Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx FertiCare, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955000525,
NDC 57955-0005-2
Class I Lot: 062615E Exp.
06/18 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Prejudiced, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955100027, NDC
57955-2322-2
Class I Lot: 062615D Exp.
Unknown Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Hydration, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville,
Class I
Lots: 062615B Exp. 06/18; 121916D
Exp. 12/19; 092617E Exp.
Microbial contamination
King Bio Inc.
Page 78 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
NC 28806 USA, UPC 357955010029, NDC
57955-0100-2
09/19
Drugs
Dr. King's SafeCare Rx AddictaPlex, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955300021, NDC
57955-3003-2
Class I Lot: 062415R Exp.
06/18 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Swollen Glands Relief, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955012122, NDC
57955-0121-2
Class I
Lots: 081315L Exp. 08/18; 062415K
Exp. 06/18; 120816F Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Teeth & Gum Formula, 2
fl. oz. (59 mL), NDC 57955-0073-2 UPC
357955007326 King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA
Class I
Lots: 062415E Exp. 06/18; 071116D
Exp. 07/18; 121317H Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Stubborn & Contentious, 2
fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955103028, NDC
57955-1031-2
Class I
Lots: 062316A Exp. 06/19; 101716D
Exp. 10/19; 122216D Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Ear Relief Formula, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955015727, NDC
57955-0154-2
Class I Lots: 062215F Exp.
06/18; 091316A Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx First Aid for Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955177029, NDC
57955-1770-2
Class I
Lots: 072815Q Exp. 07/18; 081815E
Exp. 08/18; 091216F Exp.
09/19; 071317A Exp. 07/19
Microbial contamination
King Bio Inc.
Page 79 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
Dr. King's SafeCare Rx Nausea & Motion
Sickness, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955005520,
NDC 57955-0055-2
Class I
Lots: 072815T Exp. 07/18; 071116F
Exp. 07/19; 122216F Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies: Eggs & Meats, 2
fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955220220, NDC
57955-2207-2
Class I
Lots: 081715D Exp. 08/18; 071116E
Exp. 07/19; 091616E Exp.
09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Tinnitus Relief, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955027522, NDC
57955-0275-2
Class I
Lots: 111417D Exp. 11/19; 070815D
Exp. 07/18; 090816J Exp.
09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Gambling, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955301028,
NDC 57955-3011-2
Class I Lot: 063016G Exp.
06/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx No Sweat/Anti-Perspirant, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955008521, NDC
57955-0085-2
Class I Lot: 063016E Exp.
06/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Self-Abuse, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955107026,
NDC 57955-1071-2
Class I Lots: 072815P Exp.
07/18; 111016D Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Heartache, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC
Class I Lots: 082015A Exp.
08/18; 072516F Exp. 07/19
Microbial contamination
King Bio Inc.
Page 80 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
357955203025, NDC 57955-2030-2
Drugs
Dr. King's SafeCare Rx CS-Pain Reliever, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955021728, NDC
57955-0217-2
Class I Lots: 071116H Exp.
07/19; 122216C Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx ChemoClenz, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955007128, NDC
57955-0071-2
Class I Lots: 062415G Exp.
06/18; 080916X Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Diarrhea Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955002024, NDC
57955-0020-2
Class I Lots: 072815N Exp.
07/18; 081816A Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Menopause Relief, 2 fl. oz.
(59 mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955000624, NDC
57955-0006-2
Class I Lots: 072815C Exp. 07/18; 092216M
Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies: Fragrances &
Phenolics, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955220022,
NDC 57955-2205-2
Class I Lots: 072115B Exp.
07/18; 122116B Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Environmental
Adaptation: Weather Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955028727,
NDC 57955-0287-2
Class I
Lots: 072516M Exp. 07/19;
082615B Exp. 08/18
Microbial contamination
King Bio Inc.
Page 81 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
Dr. King's SafeCare Rx Allergy & Red Eye Relief, 2
fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955016427, NDC
57955-0164-2
Class I Lots: 072816B Exp.
07/19; 080315B Exp. 08/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Criticize & Contradict, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955108023, NDC
57955-1081-2
Class I Lot: 080315J Exp.
08/18 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx CS-Lymph Hodgkins, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955021520, NDC
57955-0215-2
Class I Lots: 080315F Exp.
08/18; 121916B Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Liver Detox, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955006220, NDC
57955-0062-2
Class I
Lots: 073115F Exp. 07/18; 030916M
Exp. 03/19; 080916W Exp.
08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies Rocky Mtns. U.S., 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955260325, NDC
57955-0062-2
Class I Lot: 073115E Exp.
07/18 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx CataCure, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955011224,
NDC 57955-0112-2
Class I Lots: 072815Y Exp.
07/18; 080916L Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Mental Alertness For
Seniors, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Class I Lots: 072815R Exp.
07/18; 090116D Exp. 09/19
Microbial contamination
King Bio Inc.
Page 82 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drive, Asheville, NC 28806 USA, UPC 357955156024,
NDC 57955-1561-2
Drugs
Dr. King's SafeCare Rx Environmental Adaptation Cold/Dry, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955028321,
NDC 57955-0288-2
Class I Lot: 062916E Exp.
06/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Environmental Adaptation
Hot/Humid, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955028529, NDC
57955-0285-2
Class I
Lots; 081015K Exp. 08/18; 071316H
Exp. 07/19; 111716J Exp.
11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Aller-Detox: Indoor
Pollution Control, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955240129, NDC
57955-2408-2
Class I Lot: 080415F Exp.
08/18 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx ApoPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806 USA, UPC 357955006725,
NDC 57955-0067-2
Class I Lots: 081715F Exp.
08/18; 091616J Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Muscle Maximizer, 2 fl. oz.
(59 mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955013327, NDC
57955-0133-2
Class I Lot: 081616C Exp.
08/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Acne Clear, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955004127, NDC
Class I Lots: 091616K Exp.
09/19; 081617A Exp. 08/19
Microbial contamination
King Bio Inc.
Page 83 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
57955-0041-2
Drugs
Dr. King's SafeCare Rx Aller-Detox: Cosmetics & Household, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955240327, NDC
57955-2407-2
Class I Lot: 081015L Exp.
08/18 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Water Retention Control, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955027829, NDC
57955-0278-2
Class I Lot: 081015E Exp.
08/18 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Birth Ease, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955000228, NDC
57955-0002-2
Class I Lot: 090116E Exp.
09/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Hangover Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955011323, NDC
57955-0113-2
Class I Lots: 083115A Exp.
08/18; 091416E Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Appetite Enhancer, 2 fl.
oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955012825, NDC
57955-0128-2
Class I
Lots: 091015C Exp. 09/18; 082516B
Exp. 08/19; 022317F Exp.
02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies: Nightshades, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955250029, NDC
57955-2502-2
Class I Lot: 082316C Exp.
08/19 Microbial
contamination King Bio
Inc.
Drugs Dr. King's SafeCare Rx Class I Lots: 082316B Exp. Microbial King Bio
Page 84 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Verbal Anger, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955106029, NDC
57955-1061-2
08/19; 100115D Exp. 10/18
contamination Inc.
Drugs
Dr. King's SafeCare Rx Shy, 2 fl. oz. (59 mL), King Bio,
Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955275022, NDC
57955-2751-2
Class I Lot: 091616F Exp.
09/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Restless Mind, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955153023, NDC
57955-1531-2
Class I
Lots: 091415A Exp. 09/18; 113015K
Exp. 11/18; 122915A Exp.
12/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Procrastination, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955276029, NDC
57955-2761-2
Class I Lots: 091715C Exp.
09/18; 091316C Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Allergies: Fruits &
Vegetables, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955250128, NDC
57955-2501-2
Class I Lots: 112117E Exp.
11/19; 091216B Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955303022, NDC
57955-3031-2
Class I Lots: 091015N Exp.
09/18; 111716H Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx GynePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Drive, Asheville, NC 28806
Class I Lots: 091015F Exp.
09/18; 100416C Exp. 10/19
Microbial contamination
King Bio Inc.
Page 85 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
USA, UPC 357955000723, NDC 57955-0007-2
Drugs
Dr. King's SafeCare Rx Physical Anger, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955101024, NDC
57955-1011-2
Class I Lots: 112117A Exp.
11/19; 091015E Exp. 09/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Sporting Edge, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 35795500312, NDC
57955-0031-2
Class I Lots: 122815C Exp.
12/18; 101716A Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Poison Ivy & Oak Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Asheville, NC 28806 USA, UPC 357955011620, NDC
57955-0116-2
Class I Lots: 091015L Exp.
09/18; 092216F Exp. 09/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx EMF Detox, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955040026,
NDC 57955-0420-2
Class I Lot: 110317D Exp.
11/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Overly-Sensitive, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955207023, NDC
57955-2071-2
Class I Lot: 112117H Exp.
11/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Neglectful, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955255024, NDC
57955-2551-2
Class I Lot: 112916A Exp.
11/19 Microbial
contamination King Bio
Inc.
Drugs Dr. King's SafeCare Rx CS-Stomach, 2 fl. oz. (59 mL),
Class I Lot: 112916D Exp.
11/19 Microbial
contamination King Bio
Inc.
Page 86 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955022022,
NDC 57955-0220-2
Drugs
Dr. King's SafeCare Rx PSOR Miasm, 2 fl. oz. (59
mL), King Bio, Inc., 3 Westside Drive, Asheville,
NC 28806 USA, UPC 357955030126, NDC
57955-0307-2
Class I Lot: 120217D Exp.
12/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Foul Bowel, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955031925,
NDC 57955-0319-2
Class I Lot: 120516C Exp.
11/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Claustrophobia, 2 fl. oz. (59 mL), King Bio, Inc., 3
Westside Drive, Asheville, NC 28806 USA, UPC 357955182023, NDC
57955-1822-2
Class I Lot: 120816D Exp.
12/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Athlete's Foot Fighter, 2 fl. oz. (59 mL), King Bio, Inc.,
3 Westside Drive, Asheville, NC 28806 USA, UPC 357955012924, NDC
57955-0129-2
Class I Lot: 121016A Exp.
12/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx CS-Ovary, 2 fl. oz. (59 mL),
King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021629,
NDC 57955-0216-2
Class I Lots: 123115A Exp.
12/18; 122216J Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
People's Best Arnica Gel Homeopathic Medicine
Pain Relief, Net Wt. 2.6 oz (73 g), www.kingbio.com, UPC 357955320326, NDC
57955-3203-3
Class I
Lots: 111617ZZ Exp. 11/19;
072016ZZ Exp. 07/18; 092316ZZ
Exp. 09/18
Microbial contamination
King Bio Inc.
Drugs Aquaflora High Potency
Candida Control Program Class I
Lots: 011017A Exp. 01/20; 033116T
Microbial contamination
King Bio Inc.
Page 87 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Homeopathic Formula, Net 16 fl. oz. (1 pt) 473 mL, Manufactured by:
King Bio, Inc. 3 Westside Dr. Asheville, NC 28806
USA, UPC 357955160366, NDC 57955-1603-6
Exp. 03/19; 052516R Exp.
05/19; 122815A Exp. 12/18
Drugs
Aquaflora Phase II Candida Control Program,
Net 16 fl. oz. (1 PT) 473 mL, Homeopathic
Formula, Manufactured by: King Bio, Inc. 3
Westside Dr. Asheville, NC 28806 USA, UPC
357955160267, NDC 57955-1602-6
Class I
Lots: 010518G Exp. 07/18; 011617F
Exp. 01/20; 021016G Exp.
02/19; 051716P Exp. 02/19;
072315A Exp. 07/18
Microbial contamination
King Bio Inc.
Drugs
Aquaflora Phase I Candida Control Program, Net 16
fl. oz. (1 PT) 473 mL, Homeopathic Formula, Manufactured by: King Bio, Inc. 3 Westside Dr.
Asheville, NC 28806 USA, UPC 357955160168, NDC
57955-1601-6
Class I
Lots: 022218D Exp. 02/20; 100917D
Exp. 10/19; 021717A Exp.
02/20; 041816B Exp. 04/19;
062816F Exp. 06/19; 122815B
Exp. 12/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Aquaflora Enzyme Restoration
Upper GI Homeopathic, 2 fl. oz. (59 mL), King Bio,
Inc. 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955232124, NDC
57955-3321-2
Class I
Lots: 102016H Exp. 10/19; 010518E
Exp. 01/20; 050616A Exp.
05/19
Microbial contamination
King Bio Inc.
Drugs
Aquaflora Heavy Metal Detox Candida, 2 fl. oz. (59
mL), Homeopathic, King Bio, Inc. 3 Westside Dr.
Asheville, NC 28806 USA, NDC 57955-2281-2
Class I Lot: 080216A Exp.
08/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Aquaflora Probiotic Restoration
Lower GI Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,
Class I
Lots: 020618D Exp. 02/20; 030916P
Exp. 03/19; 041215I Exp.
04/18; 072216L
Microbial contamination
King Bio Inc.
Page 88 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Asheville, NC 28806 USA, UPC 357955232025, NDC
57955-3320-2
Exp. 07/19
Drugs
Safecare+ Southeast Regional Allergies
Homeopathic Non-Drowsy Taste Free, Oral Spray, 1 fl
oz (29.6 mL), UPC 357955834519, NDC
57955-8345-1
Class I Lots: 013017K Exp.
01/20; 080515A Exp. 08/18
Microbial contamination
King Bio Inc.
Drugs
Safecare+ AllergyCare Homeopathic Non-Drowsy Taste-Free, Oral Spray, 1 fl
oz (29.6 mL), UPC 357955404316, NDC
57955-4043-1
Class I Lots: 021717E Exp.
02/20; 091015R Exp. 09/18
Microbial contamination
King Bio Inc.
Drugs
Safecare+ AsthmaCare Homeopathic, Not a
Rescue Inhaler, 1 fl oz (29.6 mL), UPC
357955704416, NDC 57955-7044-1
Class I
Lots: 030316B Exp. 03/19; 061715A
Exp. 06/18; 061715B Exp.
06/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Safecare+ AsthmaCare
Homeopathic, Not a Rescue Inhaler, 2 fl oz (59 mL), UPC 357955404422,
NDC 57955-4044-1
Class I
Lots: 122216K Exp. 12/19; 120217P
Exp. 12/19; 111117C Exp.
11/19; 083116C Exp. 08/19;
082316E Exp. 08/19; 072015A
Exp. 07/18; 062716C Exp.
06/19; 062316B Exp. 06/19;
062218C Exp. 06/20; 052218C
Exp. 05/20; 052118C Exp.
05/20; 051716J Exp. 05/19;
041816C Exp. 04/19; 030316A
Exp. 03/19; 022317H Exp.
02/20; 111516H
Microbial contamination
King Bio Inc.
Page 89 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Exp. 11/19; 091815A Exp.
09/18; 062718C Exp. 06/20;
081815A Exp. 08/18
Drugs
Safecare+ Northeast Regional Allergies Non-Drowsy Homeopathic
Taste-Free, Oral Spray, 1 fl oz (29.6 mL), UPC
357955832515, NDC 57955-8325-1
Class I Lot: 070815H Exp.
07/18 Microbial
contamination King Bio
Inc.
Drugs
NET Remedies #1 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-091515A Exp. 09/18; AUS-
081516H Exp. 08/19; AUS-
050516A Exp. 05/19; AUS-
030816A Exp. 03/19; AUS-
011117A Exp. 01/20; AUS-
011916A Exp. 01/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #10 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-101316A Exp. 10/19; AUS-
062317B Exp. 06/20; AUS-
061016C Exp. 06/19; AUS-
030816K Exp. 03/19; AUS-
011916K Exp. 01/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #11 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-050516J Exp. 05/19; AUS-
030917D Exp. 03/20; AUS-
011916L Exp. 01/19; AUS-
011117H Exp. 01/20
Microbial contamination
King Bio Inc.
Drugs NET Remedies #12
Homeopathic Preparation, Class I
Lots: AUS-101116C Exp. 10/19; AUS-
Microbial contamination
King Bio Inc.
Page 90 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
050916A Exp. 05/19; AUS-
030917E Exp. 03/20; AUS-
011916M Exp. 01/19;
AUS091515K Exp. 09/18; AUS-
030816L Exp. 03/19
Drugs
NET Remedies #2 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-011916B Exp. 01/19; AUS-
011117B Exp. 01/20; AUS-
030816B Exp. 03/19; AUS-
050516B Exp. 05/19; AUS-
081516G Exp. 08/19; AUS-
091515B Exp. 09/18
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #20 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-011916N Exp. 01/19; AUS-
050516K Exp. 05/19; AUS-091515J Exp. 09/18; AUS-
101416A Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #24 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-011916P Exp. 01/19; AUS-
030816M Exp. 03/19; AUS-
061016D Exp. 06/19; AUS-
081516A Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #25 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba
Class I
Lots: AUS-011916Q Exp. 01/19; AUS-
061016E Exp. 06/19
Microbial contamination
King Bio Inc.
Page 91 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
QLD 4350, Australia
Drugs
NET Remedies #3 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-011117C Exp. 01/20; AUS-
011916C Exp. 01/19; AUS-
030816C Exp. 03/19; AUS-
050516C Exp. 05/19; AUS-
061217A Exp. 06/20; AUS-
081516F Exp. 08/19; AUS-
091515C Exp. 09/18
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #4 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-011117D Exp. 01/20; AUS-
011916D Exp. 01/19; AUS-
030816D Exp. 03/19; AUS-
050516D Exp. 05/19; AUS-
061016A Exp. 06/19; AUS-
081516E Exp. 08/19; AUS-
091515D Exp. 09/18
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #5 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-011117E Exp. 01/20; AUS-
011916E Exp. 01/19; AUS-
030816E Exp. 03/19; AUS-
050516E Exp. 05/19; AUS-
101116A Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #6 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Class I
Lots: AUS-011916F Exp. 01/19; AUS-
030816F Exp. 03/19; AUS-
050516F Exp. 05/19; AUS-
Microbial contamination
King Bio Inc.
Page 92 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Hume Street, Toowoomba QLD 4350, Australia
050517F Exp. 05/20; AUS-
081516D Exp. 08/19; AUS-
091515E Exp. 09/18
Drugs
NET Remedies #7 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-011916H Exp. 01/19; AUS-
030816G Exp. 03/19; AUS-
030917A Exp. 03/20; AUS-
061016B Exp. 06/19; AUS-
091515F Exp. 09/18; AUS-
101116B Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #8 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-011117F Exp. 01/20; AUS-
011916G Exp. 01/19; AUS-
030816H Exp. 03/19; AUS-
030917B Exp. 03/20; AUS-
050516G Exp. 05/19; AUS-
082616A Exp. 08/19; AUS-
091515G Exp. 09/18
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #9 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-011117G Exp. 01/20; AUS-
011916J Exp. 01/19; AUS-030816J Exp. 03/19; AUS-
030917C Exp. 03/20; AUS-
050516H Exp. 05/19; AUS-
081516B Exp. 08/19; AUS-
091515H Exp. 09/18
Microbial contamination
King Bio Inc.
Page 93 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
NET Remedies #1 (Yellow Label) Homeopathic
Preparation, Oral Liquid, 57 mL, Manufacturer: King
Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD
428 Hume Street, Toowoomba QLD 4350,
Australia
Class I
Lots: AUS-041718A Exp. 04/20; AUS-
071718N Exp. 07/20; AUS-
111317C Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #10 (Maroon Label)
Homeopathic Preparation, Oral Liquid, 57 mL,
Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lots: AUS-020118H Exp. 02/20; AUS-
102617A Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #11 (Lilac Label) Homeopathic
Preparation, Oral Liquid, 57 mL, Manufacturer: King
Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD
428 Hume Street, Toowoomba QLD 4350,
Australia
Class I
Lots: AUS-072018C Exp. 07/20; AUS-
100117D Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #12 (Pink Label) Homeopathic
Preparation, Oral Liquid, 57 mL, Manufacturer: King
Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD
428 Hume Street, Toowoomba QLD 4350,
Australia
Class I
Lots: AUS-072018G Exp. 07/20; AUS-
100117E Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #2 Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I Lot: AUS-111517D
Exp. 11/19 Microbial
contamination King Bio
Inc.
Drugs NET Remedies #20 (Red, Class I Lot: AUS-031618A Microbial King Bio
Page 94 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
White and Blue Label) Homeopathic Preparation,
Oral Liquid, 57 mL, Manufacturer: King Bio
Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Exp. 03/20; AUS-111317A Exp. 11/19; AUS-
121717C Exp. 12/19
contamination Inc.
Drugs
NET Remedies #24 (Blue, White and Purple Label)
Homeopathic Preparation, Oral Liquid, 57 mL,
Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428
Hume Street, Toowoomba QLD 4350, Australia
Class I
Lot: AUS-100117H Exp. 10/19; AUS-
020118J Exp. 02/20; AUS-
041618C Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #25 (Yellow, White and Purple
Label) Homeopathic Preparation, Oral Liquid,
57 mL, Manufacturer: King Bio Inc. U.S.A. Supplier: NET (Australia) Pty LTD
428 Hume Street, Toowoomba QLD 4350,
Australia
Class I Lot: AUS-122017A
Exp. 12/19 Microbial
contamination King Bio
Inc.
Drugs
NET Remedies #3 (Blue Label) Homeopathic
Preparation, Oral Liquid, 57 mL, Manufacturer: King
Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD
428 Hume Street, Toowoomba QLD 4350,
Australia
Class I
Lots: AUS-022418A Exp. 02/20; AUS-
031618J Exp. 03/20; AUS-
041718C Exp. 04/20; AUS-
121417A Exp. 12/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #4 (Green Label) Homeopathic
Preparation, Oral Liquid, 57 mL, Manufacturer: King
Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD
428 Hume Street, Toowoomba QLD 4350,
Australia
Class I
Lots: AUS-071718R Exp. 07/20; AUS-
110117A Exp. 11/19
Microbial contamination
King Bio Inc.
Page 95 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
NET Remedies #5 (Red Label) Homeopathic
Preparation, Oral Liquid, 57 mL, Manufacturer: King
Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD
428 Hume Street, Toowoomba QLD 4350,
Australia
Class I
Lots: AUS-020118B Exp. 02/20; AUS-
022418B Exp. 02/20; AUS-
041718E Exp. 04/20; AUS-
071718S Exp. 07/20; AUS-
100117A Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #6 (Orange Label) Homeopathic
Preparation, Oral Liquid, 57 mL, Manufacturer: King
Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD
428 Hume Street, Toowoomba QLD 4350,
Australia
Class I
Lots: AUS-020118C Exp. 02/20; AUS-
022418C Exp. 02/20; AUS-
071718T Exp. 07/20; AUS-
101117C Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #7 (Aqua Blue Label) Homeopathic Preparation, Oral Liquid,
57 mL, Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD
428 Hume Street, Toowoomba QLD 4350,
Australia
Class I
Lots: AUS-020118D Exp. 02/20; AUS-
110817A Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #8 (Royal Blue Label) Homeopathic Preparation, Oral Liquid,
57 mL, Manufacturer: King Bio Inc. U.S.A. Supplier: NET (Australia) Pty LTD
428 Hume Street, Toowoomba QLD 4350,
Australia
Class I
Lots: AUS-031618B Exp. 03/20; AUS-
020118E Exp. 02/20; AUS-
041718G Exp. 04/20; AUS-
071718W Exp. 07/20; AUS-
100117B Exp. 10/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #9 (Fuschia Label) Homeopathic
Preparation, Oral Liquid, 57 mL, Manufacturer: King
Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD
428 Hume Street,
Class I
Lots: AUS-020118F Exp. 02/20; AUS-
071718Y Exp. 07/20; AUS-
100117C Exp. 10/19
Microbial contamination
King Bio Inc.
Page 96 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Toowoomba QLD 4350, Australia
Drugs
NET Remedies #8 Allergy Homeopathic Preparation,
Oral Liquid, 57 mL, NDC 57955-4208-2
Class I
Lots: NR-031516F Exp. 03/19; NR-073015E Exp.
07/18; NR-010617F Exp.
01/20; NR-011216F Exp.
01/19; NR-021717E Exp.
02/20; NR-051116C Exp.
05/19; NR-060517B Exp.
06/20; NR-061616G Exp.
06/19; NR-080116C Exp.
08/19; NR-090115E Exp.
09/18; NR-090616G Exp.
09/19; NR-101916A Exp.
10/19; NR-120815J Exp. 12/18
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #24 Day & Night Vitals Homeopathic Preparation, Oral Liquid,
57 mL, NDC 57955-4214-2
Class I
Lots: NR-031516B Exp. 03/19; NR-021717H Exp.
02/20; NR-050916C Exp.
05/19; NR-061616M Exp.
06/19; NR-090916A Exp.
09/19; NR-101416M Exp.
10/19; NR-120815B Exp.
12/18
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #1 Earth Homeopathic Preparation,
Oral Liquid, 57 mL, NDC 57955-4201-2
Class I
Lots: NR-031516N Exp. 03/19; NR-073015C Exp.
07/18; NR-010617A Exp.
Microbial contamination
King Bio Inc.
Page 97 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
01/20; NR-011216L Exp.
01/19; NR-021717A Exp.
02/20; NR-050916E Exp.
05/19; NR-060517A Exp.
06/20; NR-061616A Exp.
06/19; NR-080116D Exp.
08/19; NR-090115C Exp.
09/18; NR-090616A Exp.
09/19; NR-101416A Exp.
10/19; NR-120815A Exp.
12/18; NR-020118A Exp.
02/20; NR-022318A Exp.
02/20; NR-051618B Exp.
05/20; NR-071718E Exp.
07/20; NR-110817A Exp.
11/19; NR-103117A Exp.
10/19; NR-120317A Exp.
12/19
Drugs
NET Remedies #9 ER 911 Homeopathic Preparation,
Oral Liquid, 57 mL, NDC 57955-4209-2
Class I
Lots: NR-031816A Exp. 03/19; NR-073015F Exp.
07/18; NR-010617H Exp.
01/20; NR-011216C Exp.
01/19; NR-021717F Exp.
02/20; NR-050916A Exp.
Microbial contamination
King Bio Inc.
Page 98 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
10/19; NR-061716A Exp.
06/19; NR-080116B Exp.
08/19; NR-090115L Exp.
09/18; NR-090616H Exp.
09/19; NR-101916B Exp.
10/19; NR-120815H Exp.
12/18
Drugs
NET Remedies #5 Fire Homeopathic Preparation,
Oral Liquid, 57 mL, NDC 57955-4205-2
Class I
Lots: NR-022318E Exp. 02/20; NR-030418A Exp.
03/20; NR-051618D Exp.
05/20; NR-051818D Exp.
05/20; NR-081017E Exp.
08/19; NR-120317E Exp.
12/19; NR-121517A Exp.
12/19; NR-031516J Exp. 3/19; NR-010617E Exp.
01/20; NR011216H Exp. 01/19; NR-040417C Exp.
4/20; NR-050916D Exp. 5/19; NR-061517A Exp.
6/20; NR-061616D Exp. 6/19; NR-080116A Exp.
8/19; NR090115J Exp. 9/18; NR-090916B Exp.
9/19; NR-101416E Exp. 10/19; NR-
120815K Exp.12/18
Microbial contamination
King Bio Inc.
Page 99 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
NET Remedies #7 Flora Plus Homeopathic
Preparation, Oral Liquid, 57 mL, NDC 57955-4207-2
Class I
Lots: NR-090115K Exp. 09/18; NR-031516G Exp.
03/19; NR-011216E Exp.
10/19; NR-021717D Exp.
02/20; NR-042717C Exp.
04/20; NR-061616F Exp.
06/19; NR-090616F Exp.
09/19; NR-101416G Exp.
10/19; NR-120815M Exp.
12/18; NR-020118H Exp.
02/20; NR-020618J Exp. 02/20; NR-081017H Exp.
08/19; NR-101117E Exp.
10/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #12 Flu Immune Homeopathic
Preparation, Oral Liquid, 57 mL, NDC 57955-4212-2
Class I
Lots: NR-010617L Exp. 01/20; NR-011216D Exp.
01/19; NR-021717G Exp.
10/19; NR-040417K Exp.
04/20; NR-061616K Exp.
06/19; NR-090115G Exp.
09/18; NR-090616K Exp.
09/19; NR-101416K Exp.
10/19; NR-120815D Exp.
12/18; NR-010318A Exp.
01/20; NR-020118N Exp.
Microbial contamination
King Bio Inc.
Page 100 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
02/20; NR-051618G Exp.
05/20
Drugs
NET Remedies #2 Metal Homeopathic Preparation,
Oral Liquid, 57 mL, NDC 57955-4202-2
Class I
Lots: NR-031516M Exp. 03/19; NR-073015D Exp.
09/19; NR-010617B Exp.
01/20; NR-011216M Exp.
01/19; NR-042717D Exp.
09/19; NR-051116B Exp.
05/19; NR-061616N Exp.
06/19; NR-080116E Exp.
08/19; NR-090115B Exp.
09/18; NR-090616B Exp.
09/19; NR-101416B Exp.
10/19; NR-120815R Exp.
12/18; NR-081017B Exp.
08/19; NR-020118B Exp.
02/20; NR-022318B Exp.
02/20; NR-101017B Exp.
10/19; NR-120317B Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #20 Pain Relief Homeopathic
Preparation, Oral Liquid, 57 mL, NDC 57955-4213-2
Class I
Lots: NR-010617M Exp. 01/20; NR-031516C Exp.
03/19; NR-061616L Exp.
06/19; NR-090115F Exp.
09/18; NR-090616M Exp.
Microbial contamination
King Bio Inc.
Page 101 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
09/19; NR-101416L Exp.
10/19; NR-120815C Exp.
12/18; NR-020118P Exp.
02/20; NR-022318K Exp.
02/20; NR-022318M Exp.
02/20; NR-052517A Exp.
05/20; NR-060517F Exp.
06/20; NR-060618A Exp.
06/20; NR-061418A Exp.
06/20; NR-121417B Exp.
12/19
Drugs
NET Remedies #6 Para Solve Homeopathic
Preparation, Oral Liquid, 57 mL, NDC 57955-4206-2
Class I
Lots: NR-031516H Exp. 03/19; NR-011216G Exp.
01/19; NR-021717C Exp.
02/20; NR-040417D Exp.
04/20; NR-061616E Exp.
06/19; NR-090115H Exp.
09/19; NR-090616E Exp.
09/19; NR-101416F Exp.
10/19; NR-120815L Exp.
12/18; NR-020118F Exp.
02/20; NR-022318F Exp.
02/20; NR-052218A Exp.
05/20; NR-071718G Exp.
Microbial contamination
King Bio Inc.
Page 102 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
07/20; NR-101117G Exp.
10/19; NR-120317F Exp.
02/19; NR-110117D Exp.
11/19
Drugs
NET Remedies #10 Scars-Adhesions Homeopathic Preparation, Oral Liquid,
57 mL, NDC 57955-4210-2
Class I
Lots: NR-031516E Exp. 03/19; NR-073015G Exp.
07/18; NR-010617J Exp. 01/20; NR-011216B Exp.
01/19; NR-040417F Exp.
04/20; NR-060517D Exp.
10/19; NR-061616H Exp.
06/19; NR-080116H Exp.
08/19; NR-090616J Exp. 09/19; NR-101416H Exp.
10/19; NR-120815G Exp.
12/18; NR-020118L Exp.
02/20; NR-022318H Exp.
02/20; NR-051618F Exp.
05/20; NR-081017N Exp.
08/19; NR-110117B Exp.
11/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #11 Visceral Polarity
Homeopathic Preparation, Oral Liquid, 57 mL, NDC
57955-4211-2
Class I
Lots: NR-031516D Exp. 03/19; NR-073015H Exp.
07/18; NR-010617K Exp.
01/20; NR-011216A Exp.
01/19; NR-050916B Exp.
Microbial contamination
King Bio Inc.
Page 103 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
05/19; NR-061616J Exp. 06/19; NR-
080116J Exp. 08/19; NR-
090115D Exp. 09/18; NR-
090816A Exp. 09/19; NR-101416J
Exp. 10/19; NR-120815F Exp.
12/18; NR-020118M Exp.
02/20; NR-072617A Exp.
07/19; NR-110117C Exp.
11/19; NR-120317L Exp.
12/19
Drugs
NET Remedies #3 Water Homeopathic Preparation,
Oral Liquid, 57 mL, NDC 57955-4203-2
Class I
Lots: NR-031516L Exp. 03/19; NR-010617C Exp.
01/20; NR-011216K Exp.
01/19; NR-050916F Exp.
05/19; NR-051917A Exp.
05/20; NR-061616B Exp.
06/19; NR-080116F Exp.
08/19; NR-090115A Exp.
09/18; NR-090616C Exp.
09/19; NR-101416C Exp.
10/19; NR-120815N Exp.
12/18; NR-020118C Exp.
02/20; NR-022318C Exp.
02/20; NR-051618A Exp.
Microbial contamination
King Bio Inc.
Page 104 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
05/20; NR-071718K Exp.
07/20; NR-081017C Exp.
08/19; NR-101017C Exp.
10/19; NR-120317C Exp.
12/19
Drugs
NET Remedies #4 Wood Homeopathic Preparation,
Oral Liquid, 57 mL, NDC 57955-4204-2
Class I
Lots: NR-031516K Exp. 03/19; NR-010617D Exp.
01/20; NR-011216J Exp. 01/19; NR-021717B Exp.
02/20; NR-051116A Exp.
05/19; NR-060217C Exp.
06/20; NR-061616C Exp.
06/19; NR-080116G Exp.
08/19; NR-090215A Exp.
09/18; NR-090616D Exp.
09/19; NR-101416D Exp.
10/19; NR-120815P Exp.
12/18; NR-081017D Exp.
08/19; NR-020118D Exp.
02/20; NR-071018A Exp.
07/20; NR-071018C Exp.
07/20; NR-071018E Exp.
07/20; NR-110317A Exp.
11/19; NR-120317D Exp.
12/19
Microbial contamination
King Bio Inc.
Page 105 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Drugs
NET Remedies #25 Yin/Yang Balance
Homeopathic Preparation, Oral Liquid, 57 mL, NDC
57955-4215-2
Class I
Lots: NR-031516A Exp. 03/19; NR-042717B Exp.
04/20; NR-090616N Exp.
09/19; NR-100115A Exp.
10/18; NR-120815E Exp.
12/18; NR-020118T Exp.
10/19; NR-022318L Exp.
02/20; NR-022318P Exp.
10/19; NR-092717A Exp.
09/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #8 Allergy (Blue Label) Homeopathic Preparation, Oral Liquid,
57 mL, NDC 57955-4208-2
Class I
Lots: NR-020618A Exp. 02/20; NR-051618E Exp.
05/20; NR-051818B Exp.
05/20; NR-101117D Exp.
10/19; NR-020118J Exp. 02/20; NR-092717B Exp.
09/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #24 Day & Night Vitals Homeopathic Preparation, Oral Liquid,
57 mL, NDC 57955-4214-2
Class I
Lots: NR-020118R Exp. 02/20; NR-071318A Exp.
07/20; NR-071318C Exp.
07/20; NR-092517A Exp.
09/19; NR-110117E Exp.
11/19; NR-120317P Exp.
12/19
Microbial contamination
King Bio Inc.
Drugs
NET Remedies #9 ER 911 Homeopathic Preparation,
Oral Liquid, 57 mL, NDC 57955-4209-2
Class I
Lots: NR-071118A Exp. 07/20; NR-071218A Exp.
07/20; NR-071218C Exp.
Microbial contamination
King Bio Inc.
Page 106 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
07/20; NR-081017M Exp.
08/19; NR-110117H Exp.
11/19; NR-020118K Exp.
02/20; NR-111517C Exp.
11/19; NR-120317J Exp. 12/19
Drugs
Dr. King's Acute Pain Relief Cooling Topical, 89
mL (topical cream), Manufactured by: King Bio, Inc. 3 Westside Dr.
Asheville, NC 28806 Imported by Ambiental
Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM
80074489 UPC 357955181439
Class I Lot: 020417ZZ Exp.
02/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Advanced Arnica Super Arnica, 59 mL,
Manufactured by: King Bio, Inc. 3 Westside Dr.
Asheville, NC 28806 Imported by Ambiental
Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM
800774305 UPC 357955181224
Class I Lot: 013117P Exp.
01/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Arthritis Pain & Joint Relief Soulagement De La Douleur Arthritique
et Articulaire, 59 mL, (liquid/liquid) DIN-HM
80035118 UPC 357955180425
Class I Lots: 011516A Exp.
01/19; 081516F Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Aquaflora
Candida High Potency 9 Multi-Strain Candida
Formula, 236 mL, (liquid/liquide), Manufactured
Class I
Lots: 022218E Exp. 02/20; 011217C
Exp. 12/20; 012116A Exp.
01/19; 092816A Exp. 09/19
Microbial contamination
King Bio Inc.
Page 107 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
by:/Fabrique par: King Bio, Inc. 3 Westside Dr.,
Asheville, NC 28805 USA Import by: Importe par: Ambiental Solutions Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80036805 UPC
357955180289
Drugs
Dr. King's Natural Medicine Anxiety & Nervousness, 59 mL,
(liquid/liquide), DIN-HM 80074778 UPC 357955181521
Class I Lots: 060917B Exp.
06/20; 021517J Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Regional
Allergies Eastern Canada, 59 mL, (liquid/liquide)
DIN-HM 80075212 UPC 357955181620
Class I Lots: 060917E Exp.
06/20; 021517K Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Multi-Strain Flu
Relief, 59 mL, (liquid/liquid), DIN-HM
80038065 UPC 357955180128
Class I Lots: 011416H Exp.
01/19; 081516E Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Regional Allergies Canadian
Prairies, 59 mL (liquid/liquide), DIN-HM
80074815 UPC 357955181729
Class I Lot: 021517L Exp.
02/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Natural Medicine Stress Control, 59 mL, (liquid/liquide), DIN-HM 80041740 UPC
357955180524
Class I Lots: 011916A Exp.
01/19; 081516G Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Respiratory
Care, 59 mL, (liquid/liquide), DIN-HM
80035323 UPC 357955180623
Class I Lots: 011516B Exp.
01/19; 082216B Exp. 08/19
Microbial contamination
King Bio Inc.
Drugs Dr. King's Natural Class I Lot: 021517M Exp. Microbial King Bio
Page 108 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Medicine Regional Allergies Western Canada,
59 mL, (liquid/liquide), DIN-HM 80074875 UPC
357955181828
02/20 contamination Inc.
Drugs
Dr. King's Appetite Enhancer Homeopathic, 2
fl oz (59 mL), King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806 USA, UPC 357955512820
Class I Lot: 121117E Exp.
12/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCare Rx Allergies Pacific U.S.
Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806 USA, UPC
357955260820, NDC 57955-2717-2
Class I
Lots: 030518R Exp. 03/20; 062415F
Exp. 06/18; 072015B Exp.
07/18
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Aller-Detox: Outdoor
Pollution Control Homeopathic, 2 fl oz (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806 USA, UPC 357955240426, NDC
57955-2404-2
Class I Lots: 070815C Exp.
07/18; 070116A Exp. 06/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Melancholic
Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806 USA, UPC
357955201021, NDC 57955-2011-2
Class I Lots: 012317F Exp.
01/20; 051216L Exp. 05/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Sinus Relief High Potency
Homeopathic Formula, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806 USA, UPC 357955013426, NDC
57955-0134-2
Class I Lots: 120816J Exp.
12/19; 123115C Exp. 12/18
Microbial contamination
King Bio Inc.
Drugs Dr. King's SafeCare Rx Class I Lots: 012317G Exp. Microbial King Bio
Page 109 www.performrx.com
200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Hyperactive High Potency Homeopathic Formula, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806 USA, UPC 357955151029, NDC
57955-1511-2
01/20 contamination Inc.
Drugs
Dr. King's Advanced Arnica Super Arnica, 59 mL,
Manufactured by: King Bio, Inc. 3 Westside Dr.
Asheville, NC 28806 Imported by Ambiental
Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM
800774304 UPC 357955181330
Class I Lot: 050117ZZ Exp.
05/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Bronchial Care, 59 mL (liquid/liquid),
Manufactured by: King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806 Imported by Ambiental
Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM
80035774 UPC 357955180425
Class I Lot: 110416A Exp.
11/19 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's Natural Medicine Kids Aquaflora
Candida Multi-Strain Formula, 118 mL (liquid), Manufactured by: King Bio, Inc., 3 Westside Dr.
Asheville, NC 28806, Imported by Ambiental
Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM
80074869 UPC 357955181941
Class I Lot: 040117A Exp.
04/20 Microbial
contamination King Bio
Inc.
Drugs
Dr. King's SafeCareRx CS-Lung High Potency
Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
Class I
Lots: 052516M Exp. 05/19;
052815E Exp. 05/18
Microbial contamination
King Bio Inc.
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
28806 USA, UPC 357955022626, NDC
57955-0226-2
Drugs
Dr. King's Natural Medicine Bug Away
Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3
Westside Dr. Asheville, NC 28806 USA, UPC
357955507726, NDC 57955-5077-2
Class I
Lots: 071116B Exp. 07/19; 050516B
Exp. 05/19; 020116A Exp.
07/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Good Mood
Enhancer Homeopathic, 2 fl oz (59 mL), King Bio,
Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955515029, NDC
57955-8150-2
Class I
Lots: 041117E Exp. 04/20; 030118H
Exp. 03/20; 040616F Exp.
04/19; 071316N Exp. 07/19;
111617C Exp. 11/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Leg Cramp &
Spasm Relief Homeopathic, 2 fl oz (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806 USA, UPC 357955543527, NDC
57955-6035-2
Class I
Lots: 102816D Exp. 10/19; 050516F
Exp. 05/19; 101416A Exp.
10/19; 123115D Exp. 12/18;
041518J Exp. 04/20
Microbial contamination
King Bio Inc.
Drugs
Dr. King's Natural Medicine Regional
Allergies Hawaii U.S. Homeopathic, 2 fl oz (59
mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806 USA, UPC 357955520620, NDC
57955-5206-2
Class I
Lots: 050216M Exp. 05/19;
070516A Exp. 07/19
Microbial contamination
King Bio Inc.
Drugs
Dr. King's SafeCare Rx Aversion to Change High
Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806
USA, UPC 357955280026,
Class I
Lots: 072015H Exp. 07/18; 111016E
Exp. 11/19; 011917N Exp.
01/20
Microbial contamination
King Bio Inc.
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
NDC 57955-2800-2
Drugs
Dr. King's SafeCare Rx Breast Cyst & Discomforts
High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
28806 USA, UPC 357955000327, NDC
57955-0003-2
Class I Lots: 040616B Exp.
04/19; 020917G Exp. 02/20
Microbial contamination
King Bio Inc.
Drugs
Levoleucovorin Injection, 250 mg/25 mL, (10
mg/mL), 25 mL Single-Use Vial, Rx only,
Manufactured for: Mylan Institutional LLC,
Rockford, IL 61103 U.S.A., Made in India. NDC:
67457-601-30
Class I Lot #: APB032,
APB033, Exp. April 2019
Presence of Particulate
Matter: particulate
matter identified as copper salts
Mylan Institution
al Inc
Drugs
Golean DETOX capsules, 14 Net: 56 g, 14 packets
containing 2 capsules per packet, 28-count capsules per box, MAT XI S.G Co., LTD, Head office: J29 Vo
Thi Sau Street, Thong Nhat Ward, Bien Hoa City, Dong
Nai Province, Viet Nam; Manufactory: 148/9 Tan
Tien Ward, Bien Hoa City, Dong Nai Province, Viet
Nam; Product distribution franshise by GoLean Detox
Enterprise 002677155-A Malaysia,
www.matxisg.com, UPC 8 938510 909013.
Class I All lots remaining
within expiry.
Marketed Without an Approved
NDA/ANDA: FDA analysis found
product to contain
undeclared sibutramine and phenolphthalein. Sibutramine is
an appetite suppressant
that was withdrawn from the US market due to safety
concerns. Phenolphthalein
was once an ingredient used
in over-the-counter
laxatives, but because of
Golean Detox US
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
concerns of carcinogenicity is not currently approved for
marketing in the US. The
presence of sibutramine and phenolphthalein in this product renders it an unapproved
drug for which the safety and
efficacy has not been
established and, therefore,
subject to recall.
Drugs
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a)
30-count (NDC: 13668-115-30), b) 90-count
(NDC: 13668-115-90), c) 1000-count (NDC: 13668-
115-10) per bottle, Rx only, Manufactured by:
Torrent Pharmaceuticals LTD, Indrad-382 721, Dist.
Mehsana Inda
Class II
Count, lots, expiry: [30-count bottle]
Lot BO31C016, exp 04/2019; [90-
count bottle] Lot BO31C016, exp 04/2019; [1000-
count bottle] Lots 4DK3C004,
4DK3C005, exp 04/2019; Lots
4DU3C040, exp 10/2019; Lots
4DU3E049, 4DU3E050, exp
05/2021
CGMP Deviations: FDA lab confirmed presence an impurity, N-
nitrosodimethylamine (NDEA)
contained in the API used to
manufacture the product above the
interim acceptable daily intake level of
0.083 parts per million.
Torrent Pharma
Inc.
Drugs
LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-
count bottle (NDC: 13668-409-90), c) 1000-count
bottle (NDC: 13668-409-10), Rx only,
Manufactured by: Torrent Pharmaceuticals LTD,
Class II
Count, lots, expiry: [30-count bottle]
Lot 4L67C035, exp 10/2019; [90-
count bottle] Lot 4L67C035,
4L67C036 exp 10/2019; [1000-count bottle] Lot 4O50C005, exp
CGMP Deviations: FDA lab confirmed presence an impurity, N-
nitrosodimethylamine (NDEA)
contained in the API used to
manufacture
Torrent Pharma
Inc.
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Indrad-382 721, Dist. Mehsana Inda
11/2019 the product above the
interim acceptable daily intake level of
0.083 parts per million.
Drugs
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-
113-90), Rx only, Manufactured by: Torrent
Pharmaceuticals LTD, Indrad-382 721, Dist.
Mehsana Inda
Class II
Count, lots, expiry: [90-count bottle]
Lot 4O49C013, exp 09/2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-
nitrosodimethylamine (NDEA)
contained in the API used to
manufacture the product above the
interim acceptable daily intake level of
0.083 parts per million.
Torrent Pharma
Inc.
Drugs
LOSARTAN POTASSIUM and
HYDROCHLOROTHIAZIDE TABLETS, USP, 100
mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by:
Torrent Pharmaceuticals LTD, Indrad-382 721, Dist.
Mehsana Inda
Class II
Count, lots, expiry: [90-count bottle]
Lot BX35C020, exp 05/2019, Lot
BX35C049, exp 08/2019; [1000-
count bottle] Lots BX35C022,
BX35C023, exp 05/2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-
nitrosodimethylamine (NDEA)
contained in the API used to
manufacture the product above the
interim acceptable daily intake level of
0.083 parts per million.
Torrent Pharma
Inc.
Drugs
LOSARTAN POTASSIUM and
HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5
mg, a) 90-count bottle
Class II
Count, lots, expiry: [90-count bottle]
Lot BP02C008, exp 03/2019; [1000-
count bottle] Lots
CGMP Deviations: FDA lab confirmed presence an impurity, N-
Torrent Pharma
Inc.
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
(NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only,
Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist.
Mehsana Inda
BEF7D006, exp 03/2020
nitrosodimethylamine (NDEA)
contained in the API used to
manufacture the product above the
interim acceptable daily intake level of
0.083 parts per million.
Drugs
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway,
AR 800-718-3588, Barcode: 62295308407
Class II Lot: 20181812@2 BUD: 06/16/2019
Lack of assurance of
sterility.
US Compounding Inc
Drugs
0.9% Sodium Chloride Injection, USP 1000 mL
flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-
7983-09
Class II Lot #: 91-016-JT,
Exp. July 01, 2020 CGMP
Deviations
ICU Medical
Inc
Drugs
Divalproex Sodium Extended-release Tablets,
USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-
533-01
Class II Lot #: C802676,
Exp 03/20
Failed Dissolution
Specifications: Out of
specification results observed
for high dissolution.
Dr. Reddy's
Laboratories, Inc.
Drugs
tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G, Distributed by:
Tubby Todd Bath Co. Vista, CA 920, (619) 894-
6560.
Class II Lot#: 5589, Exp.
08/2017
Microbial Contamination of Non-Sterile
Products: Consumer
complaint and subsequent
testing found lot to be out of
specification for mold.
Mariposa Labs LLC
Drugs Fentanyl in 0.9% Sodium Class II Lot#: 12/31/18 Labeling: Advanced
Page 115 www.performrx.com
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1
mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-
210-72
0555 21072S, Exp 3/31/2019
Incorrect expiration date.
Pharma Inc.
Drugs
Moisturizing Lubricant Eye Drops, 0.25% Sodium
Carboxymethylcellulose, 0.5 Fl OZ (15mL)
Distributed by: Walgreen Co, 200 Wilmont Rd
Deerfield IL 60015 NDC 00363-9651-01.
Class II
Lot # 8D31A, Exp: 03/20; 7H98A,
Exp: 07/19; 7L80A, Exp: 10/19.
Failed Stability Specification:
out of specification
results for Sodium
Perborate
Akorn Inc
Drugs
Topical Solution USP Hydrogen Peroxide First
Aid Antiseptic Oral Debriding Agent 32 Fl. Oz.
(1 QT) 946 mL bottle, Distributed By: Discount
Drug Mart 211 Commerce Drive, Medina, Ohio
44256 NDC 53943-871-45 UPC 0-93351-12758-8
Class II Lot: 0384244 Exp.
01/2020
Cross Contamination: Presence of IPA
in finished product.
Vi-Jon, Inc.
Drugs
Cefuroxime 10 mg/mL in Sodium Chloride,
Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only,
Leiter's (800) 292-6772- 17 Great Oaks Blvd., San
Jose, CA 95119. NDC: 70360-007-35.
Class II Lot # 1811195,
Exp. Date: 05/01/19
Incorrect Product
Formulation; compounded sterile drug
reconstituted using sterile
water instead of sterile 0.9%
Sodium Chloride.
Leiter's Enterprise
s, Inc.
Drugs
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets
Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1
Unit per carton (NDC
Class II
Lots: 7DY008A, 7DY009A, 7DY010A,
7DY011A, Exp. 08/2020
Contraceptive Tablets Out of
Sequence: Missing or
incorrect tablet placement.
Apotex Inc.
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb.
Drugs
Telmisartan and Hyrdochlorothiazide
Tablets 40mg/12.5 mg, 30-count bottles, Rx Only,
Manufactured for:Macleods Pharma
USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals
Ltd. Baddi, Himchal Pradesh INDIA, NDC
33342-128-07
Class II
Lot #: BTL703A, Exp. Feb-19;
BTL705A, Exp Apr-19; BTL706A,
BTL707A, BTL708A, Exp May-19;
BTL709A, Exp Nov-19; BTL710A,
BTL711A, BTL801A, Exp. Dec-19;
BTL802A, BTL803A, Exp.Feb-20;
BTL804A, BTL805A, Exp. Apr-20;
BTL807A, BTL807B, Exp May- 20;
BTL809A, BTL810A, Exp Jul-20;
BTL811A, Exp Sep-20; BTL812A,
BTL813A Exp Oct-20
Failed Content Uniformity
Specifications: The product is
out of specification for
blend uniformity.
Macleods Pharma Usa Inc
Drugs
Telmisartan and Hyrdochlorothiazide
Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA,
Inc. Plainsboro, NJ 08536 Manufactured by:
Macleods Pharmaceuticals Ltd. Baddi, Imachal
Pradesh, India NDC 33342-129-07
Class II
Lot #: BTM703A, BTM704A, BTM706A,
BTM707A, Exp Feb-19;
TM708A,BTM709A, Exp Apr-19;
BTM710A, Exp Jun-19; BTM711A, BTM712A, Exp
Oct-19; BTM713A,BTM714A, BTM715A, Exp
Nov-19; BTM801A, BTM802A, BTM803A,
Failed Content Uniformity
Specifications: The product is
out of specification for
blend uniformity.
Macleods Pharma Usa Inc
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
BTM804A, Exp Dec-19;
BTM806A,BTM807A, Exp Mar-20;
BTM809A Exp Apr-20; BTM810A,
BTM811A, BTM812A, Exp. Jul-
20; BTM813A, BTM814A, BTM815A, BTM816A,
BTM817A, Exp Sep-20; BTM818A, BTM819A Exp Nov-
20.
Drugs
Telmisartan and Hyrdochlorothiazide
Tablets 80 mg/25 mg, 30-count bottles, Rx Only,
Manufactured for: Macleods Pharma USA,
Inc. Plainsboro, NJ 08536 Manufactured by:
Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC
33342-130-07
Class II
Lot #: BTN703A, BTN704A Exp Feb-
19; BTN705A, BTN706A, Exp
May-19; BTN707A, Exp Jun-19;
BTN810A, Exp Jun-20; BTN811A,
BTN812A Exp Aug-20; BTN813A,
BTN814A, Exp Sep-20; BTN802A,
BTN802B, BTN803A,
BTN804A, Exp Dec-19; BTN805A,
BTN806A, BTN807A,
BTN807B, Exp Feb-20; BTN808A, Exp Apr-20; BTN809A,
BTN810A, Exp Jun-20; BTN811A,
BTN812A, Exp Aug-20; BTN813A,
BTN814A, Exp Sep-20.
Failed Content Uniformity
Specifications: The product is
out of specification for
blend uniformity.
Macleods Pharma Usa Inc
Drugs Gentamicin Sulfate
Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only,
Class II Lot 7B71A, Exp
01/2020
Failed Impurities/Degr
adation
Akorn, Inc.
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Manufactured for: Akorn, Inc., Lake Forest, IL 60045;
NDC 17478-283-10.
Specifications: High Out-of-Specification
(OOS) results for Individual and
Total Impurities that have been identified at the
18 months stability testing
time point.
Drugs
Oxygen, Refrigerated Liquid USP, Rx only,
cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home
Medical, Inc. Germantown, MD. 20875
Class II
Lot # 01005100518, 01010101918, 01011101918, 01007112118, 01001100318, 01007072518, 01017120518, 01011090518,
01002100318. No expiration date,
but an evaporation rate of
approximately 60 days from fill date
depending on head pressure of
reservoir.
CGMP Deviations
Roberts Home
Medical LLC
Drugs
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx
Only, Manufactured by: G&W Laboratories, Inc.
South Plainfield, NJ 07080, NDC 0713-0726-37
Class III
Lot #: 1009431, 1009507, Exp.
08/2020; 1009886, Exp. 09/2020
Labeling: Not Elsewhere Classified.
Mometasone Furoate Cream
has an NDC typographical
error.
ACP Nimble Buyer,
Inc.
Drugs
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a)
100-count bottles (NDC 0378-5280-01), and b)
500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan
Pharmaceuticals Inc.
Class III Lot #: 3090167,
Exp. October 2019
Failed Impurities/Degr
adation Specifications:
High out of specification
results obtained during routine stability testing
Mylan Pharmace
uticals Inc.
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
Morgantown, WV, 26505
Drugs
Oxytocin 10 Units added to NS 1000 mL (oxytocin
and 0.9% Sodium Chloride) Injectable
Solution, Approximately 1001 mL Sterile single use
bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC
42852-730-99.
Class III Lot: 12/20/18 1056
73099P, BUD: 02/03/2019
Superpotent Drug: product may contain
concentrations of oxytocin higher than
what is represented on
the label.
Advanced Pharma
Inc.
Drugs
Oxytocin 20 Units added to NS 1000 mL (oxytocin
and 0.9% Sodium Chloride) Injectable
Solution, Approximately 1002 mL Sterile single use
bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC
42852-703-99.
Class III
Lots: 12/14/18 1482 70399P,
BUD: 02/27/19; 12/14/18 1610 70399P, BUD:
02/27/19
Superpotent Drug: product may contain
concentrations of oxytocin higher than
what is represented on
the label.
Advanced Pharma
Inc.
Drugs
Oxytocin 30 Units added to NS 500 mL (oxytocin
and 0.9% Sodium Chloride) Injectable
Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of
Houston, 9265 Kirby Dr., Houston, TX 77054, NDC
42852-706-50.
Class III
Lots: 11/27/18 3177 70650P,
BUD: 02/10/2019; 11/27/18 6618 70650P, BUD: 02/10/2019;
11/28/18 7716 70650P, BUD:
02/12/19; 12/31/18 5698 70650P, BUD:
03/16/19
Superpotent Drug: product may contain
concentrations of oxytocin higher than
what is represented on
the label.
Advanced Pharma
Inc.
Drugs
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx
only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
Class III
a) 357052, exp 4/19/19 b) 356892, exp 4/16/19 and 356927, exp
4/15/19
Failed Stability Specification;
out of specification
(OOS) results for a preservative
at 9 month stability study.
Akorn Inc
Drugs
Lovastatin Tablets USP, 40 mg, packaged in a) 60-
count (NDC 68180-469-07 and b) 100-count (NDC
Class III
Lot #: a) G702755, Exp March 2020; b) G702756, Exp
March 2020
CGMP Deviations:
Finished product made
Lupin Pharmace
uticals Inc.
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals,
Inc., Baltimore, Maryland 21202; Manufactured by:
Lupin Limited, Goa 403 722 INDIA.
with lovastatin drug substance that was out of specification for
individual impurity results.
Drugs
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo
Bronx, NY 10457 Distributed by Perrigo
Allegan, MI 49010, 45802-401-09
Class III Lot #: 7DT0280, 7ET0565, Exp.
02/19
Failed Degradation/Im
purities Specifications:
Out of specification
related substance
results during stability testing.
Perrigo New York,
Inc.
Drugs
Temozolomide Capsules, 5 mg, packaged in a) 5-
count bottle (NDC 43975-252-05) b) 14-count bottle
(NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc.,
Irvine, CA 92618, Dist. By: Amerigen
Pharmaceuticals, Lyndhurst, NJ 07071
Class III
Lot #: a) 18J043A, Exp 09/30/2020, b)
18J043B, Exp 09/30/2020
Failed dissolution
specifications
Amerigen Pharmace
uticals Inc.
Drugs
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL
bottle, Rx only, Manufactured by: Lupin
Limited, Pithampur (M.P.) 454 775, INDIA, NDC
68180-422-01.
Class III
Lots: H701618, H701619,
H701620, Exp March 2019;
H702220, H702221, H702222, H702223, H702224, H702225,
H702351, Exp April 2019; H702971,
H702972, H702973, H702974, H703151, H703152,
H703153, Exp June
Failed Impurities/Degr
adation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-
specification for impurities.
Lupin Pharmace
uticals Inc.
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
2019; H703155, H703682,
H703683, Exp July 2019; H704243,
H704245, H704247, Exp
September 2019; H704707, H704709, H705038,
H705039, Exp October 2019; H705561, Exp
November 2019; H800394, H800395, H800617,
H800618, Exp January 2020;
H801585, H801586, H801721,
H801722, Exp March 2020;
H802138, H802139,
H802140, Exp April 2020; H802421,
H802707, H802718, Exp May
2020; H803187, H803188,
H803232, Exp June 2020; H803749,
H803750, Exp July 2020; H804326,
H804327, H804328, H804330, H804549, H804552, H804630,
H804632, Exp September 2020;
H805163, H805361,
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
H805362, H805676, Exp
November 2020; H805690, H805692,
H805694, Exp December 2020
Drugs
BuPROPion Hydrochloride Extended-Release Tablets,
USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC
59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd,
Roorkee, India, Marketed by: Jubilant Cadista
Pharmaceuticals Inc., Salisbury, MD
Class III
a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp.
date 11/2019
Failed Dissolution
Specifications; 9-month stability
timepoint
Jubilant Cadista
Pharmaceuticals,
Inc.
Drugs
ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4
litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons per
case, Petra Hygienic Systems, Concord, ON L4K
4RS/ Reno, NV 89511, NDC 42326-550-01, UPC 0
65936 10335 5.
Class III All Lots
Does Not Meet Monograph:
product contains,
triclosan, an ingredient that
can no longer be contained in
over-the-counter
consumer antiseptic/antib
acterial wash products.
Petra Hygienic Systems Int Ltd
Drugs
Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx
Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154
NDC: 62175-271-37
Class III
Lots: 18226783A, exp 07/2021 and 18232540A, exp
08/2021
Failed Dissolution
Specifications
Lannett Company
Inc.
Drugs
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and
b) 500 tablets (NDC
Class III
Lots: a) 22738 Exp. 07/2020 and b)
22739 Exp. 07/2020
Failed Dissolution
Specifications
AVKARE Inc.
Page 123 www.performrx.com
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Product Type
Product Description Classification Code Info Reason for
Recall Recalling
Firm
42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN
38478
Drugs
Mirapex (pramipexole dihydrochloride) Tablets,
1 mg, 100-count unit-dose tablets per folding carton,
Rx only, Distributed by: Boehringer Ingelheim (BI)
Pharmaceuticals, Inc., Ridgefield, CT 06877 USA,
Made in Germany, NDC 0597-0190-61.
Class III Lot # AA3280A, Exp SEP 2019
Failed Tablet/Capsule Specifications:
identification of low weight
tablets during routine stability
testing.
Boehringer
Ingelheim Pharmace
uticals, Inc.
*Please refer to FDA website for further information at: http://www.fda.gov/Safety/Recalls/default.htm
Page 124 www.performrx.com
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CURRENT DRUG SHORTAGES
Magnesium Sulfate Injection
February 21, 2019
Reason for the Shortage
American Regent is not currently marketing magnesium sulfate which has been unavailable since late
2012.
Fresenius Kabi has magnesium sulfate injection on shortage due to increased demand for the
product.
Pfizer has magnesium sulfate injection on shortage due to manufacturing delays.
X-Gen discontinued magnesium sulfate in April 2018.
Exela launched magnesium sulfate vials in May 2018.
WG Critical Care had magnesium sulfate injection on shortage due to increased demand for the
product.
Estimated Resupply Dates
Fresenius Kabi has magnesium sulfate 500 mg/mL 50 mL vials on back order and the company
estimates a release date of late-March 2019. Check wholesalers for inventory.
Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a
release date of December 2019. The 500 mg/mL 10 mL syringes are on back order and the company
estimates a release date of March 2019. The magnesium sulfate 40 mg/mL 1000 mL bags are on back
order and the company estimates a release date of March 2019. The 40 mg/mL 50 mL and 100 mL
bags and 80 mg/mL 50 mL bags are available in limited supply.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=21
Losartan and Hydrochlorothiazide Tablets
February 22, 2019
Reason for the Shortage Cadista did not provide a reason for the shortage.
Lupin did not provide a reason for the shortage.
Merck has Hyzaar tablets available.
Rising did not provide a reason for the shortage.
Sandoz recalled one lot of losartan and hydrochlorothiazide 100 mg/25 mg in 1000 count bottles in November 2018 due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm625492.htm.
Torrent recalled certain lots of 50 mg/ 12.5 mg in 90 and 1000 count bottles and 100mg/ 12.5 mg in 90 and 1000 count bottles in December 2018 and January 2019 due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm629693.htm.
Torrent has losartan and hydrochlorothiazide tablets available in all presentations (from lots unaffected by the recall).
Teva did not provide a reason for the shortage.
Estimated Resupply Dates
Cadista has losartan and hydrochlorothiazide tablets on back order and the company cannot estimate a release date.
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Lupin has losartan and hydrochlorothiazide tablets on allocation.
Rising has losartan and hydrochlorothiazide tablets on back order and the company cannot estimate a release date.
Sandoz has losartan and hydrochlorothiazide tablet presentations on back order and the company cannot estimate a release date.
Teva has losartan and hydrochlorothiazide 50 mg/12.5 mg tablets in 30, 90, and 1000 count bottles and 100 mg/12.5 mg tablets in 90 count bottles on back order and the company estimates a release date in early-June 2019. The 100 mg/12.5 mg tablets in 30 count and 1000 count bottles are on back order and the company estimates a release date in late-May 2019. The 100 mg/25 mg tablets in 30, 90, and 1000 count bottles are on back order and the company estimates a release date in late-June 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=529 Leuprolide Acetate 14-Day Kit February 25, 2019 Reason for the Shortage
Sun Pharma did not provide a reason for the shortage.
Sandoz states the reason for the shortage was increased demand.
Teva is not currently marketing leuprolide injection.
Estimated Resupply Dates Sun Pharma has leuprolide acetate injection on back order and the company cannot estimate a
release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=81
Letermovir Injection
February 25, 2019
Reason for the Shortage
Merck has Prevymis on shortage due to a supply disruption.
Estimated Resupply Dates
Merck has Prevymis 20 mg/mL 12 mL and 24 mL vials on back order and the company cannot
estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=487
Gentamicin Sulfate Ophthalmic Ointment
February 26, 2019
Reason for the Shortage
Akorn has Gentak ophthalmic ointment on shortage due to manufacturing delays.
Gentamicin ophthalmic solutions are not affected by this shortage.
Estimated Resupply Dates
Akorn has Gentak 3.5 gram tubes on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=412
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Calcitriol Injection
February 26, 2019
Reason for the Shortage
Akorn did not provide a reason for the shortage.
American Regent has not had product for several years.
Estimated Resupply Dates
Akorn has calcitriol 1 mcg/mL 1 mL ampules on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=464
Atropine Ophthalmic Solution
February 26, 2019
Reason for the Shortage
Akorn did not provide a reason for the atropine ophthalmic solution shortage.
Altaire has homatropine ophthalmic solution available.
Estimated Resupply Dates
Akorn has atropine ophthalmic solution in 5 mL, 10 mL, and 15 mL bottles on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=514
Isocarboxazid Tablets
February 27, 2019
Reason for the Shortage
Validus has Marplan tablets on shortage due to manufacturing delays.
Estimated Resupply Dates
Validus has Marplan on long-term back order and the company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=411
Enoxaparin Sodium Injection
February 28, 2019
Reason for the Shortage
Amphastar has enoxaparin on intermittent back order due to increased demand.
Apotex launched enoxaparin in early-2019.
Fresenius Kabi did not provide a reason for the shortage.
Sandoz discontinued enoxaparin presentations in mid-2018 due to a supplier issue.
Sanofi-Aventis did not provide a reason for the shortage.
Teva did not provide a reason for the shortage.
Winthrop did not provide a reason for the shortage.
Estimated Resupply Dates
Amphastar has enoxaparin 120 mg/0.8 mL prefilled syringes available in limited supply.
Fresenius Kabi has enoxaparin 120 mg/0.8 mL prefilled syringes on back order and the company
estimates a release date in mid- to late-March 2019.
Sanofi-Aventis has all Lovenox prefilled syringes on allocation.
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Teva has enoxaparin 150 mg/1 mL, 120 mg/0.8 mL, 100 mg/1 mL, and 80 mg/0.8 mL prefilled
syringes on allocation.
Winthrop has all enoxaparin prefilled syringes on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=466
Clomiphene Citrate Tablets
February 28, 2019
Reason for the Shortage
Par did not provide a reason for the shortage. They are the sole suppliers of clomiphene citrate
tablets.
Estimated Resupply Dates
Par has clomiphene citrate 50 mg tablets on long-term back order and the company cannot estimate
a release date
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=538
Diclofenac Potassium Tablets
February 28, 2019
Reason for the Shortage
Mylan did not provide a reason for the shortage.
Teva did not provide a reason for the shortage.
Sandoz discontinued diclofenac potassium tablets.
Estimated Resupply Dates
Mylan has diclofenac potassium 50 mg tablets on back order and the company estimates a release
date of late-April to early-May 2019.
Teva has diclofenac potassium 50 mg tablets in 100 count and 500 count on back order and the
company estimates a release date of early-June 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=537
Ciprofloxacin Oral Suspension
March 1, 2019
Reason for the Shortage
Lupin did not provide a reason for the shortage.
Bayer has Cipro oral suspension available.
Estimated Resupply Dates
Lupin has ciprofloxacin oral suspension on long-term back order and the company cannot estimate a
release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=255
Clindamycin Phosphate Injection
March 1, 2019
Reason for the Shortage
Alvogen did not provide a reason for the shortage.
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Akorn did not provide a reason for the shortage.
Baxter has clindamycin injection available.
Fresenius Kabi did not provide a reason for the shortage.
Pfizer did not provide a reason for the shortages. Pfizer discontinued Cleocin premixed bags in 2018.
Sagent has clindamycin injection available.
Sandoz has clindamycin injection available.
Estimated Resupply Dates
Akorn has clindamycin 600 mg/50 mL and 900 mg/50 mL in 5% dextrose premixes on back order and
the company cannot estimate a release date.
Alvogen has clindamycin 150 mg/mL 2 mL, 4 mL, and 6 mL ADD-Vantage vials on back order and the
company estimates a release date of 2nd quarter 2019.
Baxter has clindamycin 600 mg/50 mL in 5% dextrose on back order and the company cannot
estimate a release date.
Fresenius Kabi has short-dated clindamycin 150 mg/mL 4 mL and 6 mL vials available with an
expiration date of <9 months for the 4 mL vials and <8 months for the 6 mL vials.
Pfizer has Cleocin 150 mg/mL 2 mL, 4 mL, and 6 mL ADD-Vantage vials on back order and the
company estimates a release date of September 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=97
Desiccated Thyroid Tablets
March 1, 2019
Reason for the Shortage
Acella has NP Thyroid available.
Allergan has Armour Thyroid available.
RLC states the reason for the shortage is increased demand and difficulty obtaining raw materials.
Estimated Resupply Dates
RLC has Nature-Throid 16.25 mg, 194.4 mg, 260 mg, and 325 mg tablets on back order and the
company cannot estimate a release date. Westhroid presentations are also on back order and the
company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=350
Dicyclomine Injection
March 1, 2019
Reason for the Shortage
Allergan has Bentyl injection available.
American Regent did not provide a reason for the shortage.
Hikma did not provide a reason for the shortage.
Nexus has dicyclomine injection for intramuscular use available.
Estimated Resupply Dates
Hikma has short-dated dicyclomine 10 mg/mL 2 mL vials available with an expiration date of May
2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=520
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Erythromycin Ophthalmic Ointment
March 1, 2019
Reason for the Shortage
Akorn did not provide a reason for the shortage.
Bausch Health did not provide a reason for the shortage.
Perrigo has erythromycin ophthalmic ointment on shortage due to increased demand.
Estimated Resupply Dates
Akorn has erythromycin 0.5% ophthalmic ointment in 3.5 gram tubes on allocation.
Bausch Health has erythromycin 0.5% ophthalmic ointment in 1 gram and 3.5 gram tubes on back
order and the company estimates a release date of mid-March 2019 for the 1 gram tubes and early-
to mid-April 2019 for the 3.5 gram tubes.
Perrigo has erythromycin 0.5% ophthalmic ointment in 1 gram tubes in 50 count and 3.5 gram tubes
in 24 count on back order and the company estimates a release date of April 2019 for the 1 gram
tubes and August 2019 for the 3.5 gram tubes.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=540
Levetiracetam Immediate-Release Tablets
March 1, 2019
Reason for the Shortage
Accord has levetiracetam immediate-release tablets available.
Aurobindo has levetiracetam immediate-release tablets available.
Camber did not provide a reason for the shortage.
Lupin did not provide a reason for the shortage.
Major did not provide a reason for the shortage.
Mylan did not provide a reason for the shortage.
Torrent representatives were not available to provide information.
OWP representatives were not available to provide information on Roweepra availability.
UCB has Keppra immediate-release tablets available.
Estimated Resupply Dates
Camber has levetiracetam immediate-release tablets on intermittent back order and the company is
allocating product as it becomes available.
Lupin has levetiracetam immediate-release tablets on back order and the company estimates a
release date in first quarter 2019.
Major has levetiracetam immediate-release tablets on back order and the company cannot estimate
a release date.
Mylan has levetiracetam 250 mg and 1000 mg immediate-release tablets in all sizes on back order
and the company cannot estimate a release date. The 500 mg and 750 mg immediate-release tablets
in 120 and 500 count bottles are on back order and the company estimates a release date in mid-
April 2019. The 500 mg and 750 mg immediate-release tablets in 100 count unit dose packages are
on back order and the company estimates a release date of mid-March 2019 for the 500 mg tablets
and mid-May 2019 for the 750 mg tablets.
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https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=533
Lorazepam Injection
March 1, 2019
Reason for the Shortage
Bedford discontinued lorazepam injection in May, 2011.[1]
Hikma has product on shortage due to manufacturing delays.[2]
Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer
discontinued 4 mg/mL 10 mL vials in December 2017.[3]
Akorn has not provided a reason for the shortage.[4]
Amphastar has product available.[5]
Estimated Resupply Dates
Akorn has lorazepam 2 mg/mL 1 mL vials on allocation.[4]
Hikma has Ativan 2 mg/mL 1 mL vials on back order and the company estimates a release date of
March 2019.[2]
Pfizer has lorazepam 2 mg/mL 10 mL vials on back order and the company estimates a release date
of March 2019. The 2 mg/mL 1 mL Carpuject syringes and 4 mg/mL 1 mL vials are on back order and
the company estimates a release date of June 2019. The 4 mg/mL 1 mL Carpuject syringes are on
back order and the company estimates a release date of March 2020.[3]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=87
Methocarbamol Tablets
March 1, 2019
Reason for the Shortage
Bayshore, Solco, Virtus, Hikma, and Endo did not provide a reason for the shortage.
Camber states the shortage is due to an API shortage.
Par discontinued methocarbamol tablets in July 2018.
Estimated Resupply Dates
Bayshore has all methocarbamol presentations on allocation.
Hikma has methocarbamol 500 mg and 750 mg tablets in 500 count on back order and the company
estimates a release date of March 2019. Methocarbamol 500 mg and 750 mg tablets in 100 count
are on back order and the company cannot estimate a release date.
Solco has all methocarbamol presentations on allocation.
Virtus has all methocarbamol tablets on back order and the company cannot estimate a release date.
Endo has Robaxin 750 mg tablets in 100 count on back order and the company cannot estimate a
release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=423
Methylphenidate Extended-Release Oral Suspension and Chewable Tablets
March 1, 2019
Reason for the Shortage
Tris Pharma has Quillivant XR oral suspension and QuilliChew ER chewable tablets available.
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200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=373
Metoprolol Injection
March 1, 2019
Reason for the Shortage
Alvogen has metoprolol injection available.[1]
American Regent is not currently marketing metoprolol injection.[2]
Athenex has metoprolol injection available.[3]
Baxter did not provide a reason for the shortage.[4]
Fresenius Kabi has metoprolol injection on shortage due to increased demand.[5]
Mylan Institutional acquired metoprolol injection from Sagent. They discontinued metoprolol
injection in March 2018.[6]
Pfizer has metoprolol injection on shortage due to manufacturing delays.[7]
Hikma did not provide a reason for the shortage.[8]
Estimated Resupply Dates
Baxter (formerly Claris) has metoprolol 1 mg/mL 5 mL vials on back order and the company
estimates a release date of April 2019.[4]
Fresenius Kabi has metoprolol 1 mg/mL 5 mL vials on back order and the company estimates a
release date of mid- to late-March 2019.[5]
Hikma has metoprolol 1 mg/mL 5 mL and 10 mL vials on back order and the company estimates a
release date of March to April 2019.[8]
Pfizer has metoprolol 1 mg/mL 5 mL Carpuject syringes on back order and the company estimates a
release date of 1st quarter 2020. The 1 mg/mL 5 mL ampules are on back order and the company
estimates a release date of December 2019. The 1 mg/mL 5 mL vials are on back order and the
company estimates a release date of April 2019.[7]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=363
Recombinant Zoster Vaccine (Shingrix)
March 1, 2019
Reason for the Shortage
GlaxoSmithKline has Shingrix on shortage due to high demand for the product.
Estimated Resupply Dates
GlaxoSmithKline has Shingrix on intermittent back order and the company is shipping orders
according to order date and supply available.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=427
Scopolamine Transdermal System
March 1, 2019
Reason for the Shortage
Baxter did not provide a reason for the shortage.
GlaxoSmithKline states the shortage was due to increased demand.
Perrigo did not provide a reason for the shortage.
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Estimated Resupply Dates
Baxter has Transderm Scop 1.5 mg patches in 10 and 24 count on back order and the company
cannot estimate release dates.
Perrigo has scopolamine patches on back order and the company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=442
Sodium Polystyrene Sulfonate Powder
March 1, 2019
Reason for the Shortage
CMP Pharma has sodium polystyrene sulfonate on back order due to a raw material shortage.
ECI Pharmaceuticals did not provide a reason for the shortage.
KVK-Tech did not provide a reason for the shortage.
Sunrise Pharmaceuticals has sodium polystyrene sulfonate on back order due to a raw material
shortage.
Trigen did not provide a reason for the shortage.
Estimated Resupply Dates
CMP Pharma has sodium polystyrene sulfonate in 454 gram bottles on back order and the company
cannot estimate a release date.
ECI Pharmaceuticals has sodium polystyrene sulfonate in 454 gram bottles on back order and the
company estimates a release date of early-April 2019.
KVK-Tech has sodium polystyrene sulfonate in 454 gram bottles on back order and the company
estimates a release date of late-March 2019.
Sunrise Pharmaceuticals has sodium polystyrene sulfonate in 15 gram and 454 gram bottles on
intermittent back order and the company cannot estimate release dates.
Trigen has sodium polystyrene sulfonate in 454 gram bottles on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=523
Spironolactone Tablets
March 1, 2019
Reason for the Shortage
Accord, Amneal, Cadista, Mylan, and Sun Pharma did not provide a reason for the shortage.
Par discontinued spironolactone tablets in August 2018.
Pfizer states Aldactone is on shortage due to manufacturing delays.
Estimated Resupply Dates
Accord has spironolactone 50 mg tablets in 500 count bottles and 100 mg tablets in 500 count
bottles on back order and the company estimates a release date of mid-March 2019.
Amneal has all spironolactone presentations on back order and the company cannot estimate a
release date.
Mylan has spironolactone 50 mg tablets in 100 and 500 count bottles and 100 mg tablets in 100
count bottles are on back order and the company estimates release dates of mid-March 2019 for the
50 mg tablets in 100 count and 500 count bottles and early-March 2019 for the 100 mg tablets in 100
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count bottles. The 25 mg tablets in 100 count bottles are on back order and the company estimates a
release date of early-March 2019.
Par has most presentations on back order and the company cannot estimate a release date.
Pfizer has Aldactone 25 mg tablets in 100 count bottles and 50 mg tablets in 100 count bottles on
back order and the company estimates a release date of March 2019.
Sun Pharma has spironolactone 25 mg tablets in 100 and 1000 count, 50 mg tablets in 60 and 500
count, and 100 mg in 100 count on back order and the company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=447
Sterile Water for Injection - Small Volume Vials
March 1, 2019
Reason for the Shortage
American Regent has sterile water for injection available.
Fresenius Kabi has sterile water on shortage due to increased demand.
Hikma has sterile water for injection available.
Pfizer has sterile water for injection in vials on shortage due to increased demand.
Estimated Resupply Dates
Fresenius Kabi has sterile water for injection 100 mL vials on back order and the company cannot
estimate a release date. Check wholesalers for inventory.
Pfizer has sterile water for injection 50 mL vials on back order and the company estimates a release
date of March 2019. The 20 mL and 100 mL vials are available in limited supply.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=375
Dobutamine Injection
March 4, 2019
Reason for the Shortage
Baxter has dobutamine available.
Pfizer has dobutamine on shortage due to manufacturing delays.
Estimated Resupply Dates
Pfizer has dobutamine 12.5 mg/mL 20 mL and 40 mL latex-free vials on back order with an estimated
release date of March 2020 for the 20 mL vials and December 2019 for the 40 mL vials.
Pfizer has dobutamine 1 mg/mL in 250 mL bags on back order and the company estimates a release
date of June 2019. The dobutamine 4 mg/mL 250 mL bags are available in limited supply.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=296
Enalaprilat Injection
March 4, 2019
Reason for the Shortage
Hikma did not provide a reason for the shortage.
Pfizer has enalaprilat injection on shortage due to manufacturing delays.
Estimated Resupply Dates
Hikma has enalaprilat 1.25 mg/mL 1 mL and 2 mL vials on allocation.
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Pfizer has enalaprilat 1.25 mg/mL 1 mL and 2 mL vials on back order and the company estimates a
release date of March 2020.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=488
Epinephrine Injection
March 4, 2019
Reason for the Shortage
Amphastar stopped distributing epinephrine 1 mg/mL 30 mL vials on May 10, 2017. They are
continuing to supply 0.1 mg/mL 10 mL syringes. These are on shortage due to increased demand.[1]
Pfizer stopped distributing epinephrine 1 mg/mL presentations on May 10, 2017.[2]
BPI has epinephrine 1 mg/mL 2 mL ampules available.[3]
Par has Adrenalin 1 mg/mL 1 mL and 30 mL vials available.[4]
Estimated Resupply Dates
Amphastar has epinephrine 0.1 mg/mL 10 mL syringes on allocation.[1]
Pfizer has epinephrine 0.1 mg/mL 10 mL syringes on back order and the company estimates a release
date of March 2019.[2]
Snap Medical Industries has the Epinephrine Snap-V Kit available. Each kit contains an epinephrine 1
mg/mL 1 mL vial, (3) 1 mL luer lock syringes, and (3) 23-gauge 1-inch needles.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=313
Furosemide Tablets
March 4, 2019
Reason for the Shortage
Major discontinued furosemide tablets in early-2018.
Mylan did not provide a reason for the shortage.
Hikma states the shortage is due to manufacturing delays.
Sandoz discontinued furosemide tablets in late-August 2017.
Teva discontinued furosemide tablets in June 2018
Estimated Resupply Dates
Hikma has furosemide 20 mg tablets in 100 count unit dose packs, 40 mg tablets in 100 count unit
dose packs, 40 mg tablets in 100 count bottles, 40 mg tablets in 1000 count bottles, and 80 mg
tablets in 100 count unit dose packs on allocation.
Mylan has furosemide 40 mg tablets in 1000 count on back order and the company estimates a
release date of late-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=339
Mycophenolate Mofetil Capsules and Tablets
March 4, 2019
Reason for the Shortage
Accord did not provide a reason for the shortage.
Ascend did not provide a reason for the shortage.
Hikma did not provide a reason for the shortage.
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Mylan did not provide a reason for the shortage.
Genentech has Cellcept available.
Sandoz did not provide a reason for the shortage.
Estimated Resupply Dates
Accord has all mycophenolate mofetil presentations on allocation.
Ascend has all mycophenolate mofetil presentations on intermittent back order and the company is
releasing product as it becomes available.
Hikma has mycophenolate mofetil 250 mg capsules in 100 count and 500 count and 500 mg tablets
in 100 count and 500 count on allocation.
Mylan has mycophenolate mofetil 250 mg capsules in 500 count on back order and the company
estimates a release date of late-March 2019. The 500 mg tablets in 500 count are on back order and
the company estimates a release date of mid-April 2019.
Sandoz has mycophenolate mofetil 250 mg capsules in 1440 count are on back order and the
company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=448
Phenytoin Sodium Injection
March 4, 2019
Reason for the Shortage
Hikma did not provide a reason for this shortage.
X-Gen Pharmaceuticals discontinued their phenytoin sodium presentations in April 2017.
Estimated Resupply Dates
Hikma has phenytoin sodium 50 mg/mL 2 mL and 5 mL vials available.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=406
Sodium Bicarbonate Injection
March 4, 2019
Reason for the Shortage
Amphastar has sodium bicarbonate injection available.[1]
Pfizer has sodium bicarbonate injection on shortage due to manufacturing delays.[2]
Fresenius Kabi had sodium bicarbonate injection temporarily available, but have run out of stock,
there is more in production at this time.[3]
Estimated Resupply Dates
Fresenius Kabi has 8.4% sodium bicarbonate 50 mL vials on back order and the company estimates a
release date of mid- to late-March 2019.[3]
Pfizer has sodium bicarbonate 4.2% 10 mL LifeShield syringes and 7.5% 50 mL syringes available in
limited supply. The 8.4% 10 mL syringes are on back order and the company estimates a release date
of March 2019. The 8.4% 50 mL vials are on back order and the company estimates a release date of
March 2019. The 8.4% 50 mL syringes are on back order and the company estimates a release date
of April 2019.[2]
Pfizer has Neut 4% 5 mL vials on back order and the company estimates a release date of May
2019.[2]
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https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=293
Sodium Phosphate Injection
March 4, 2019
Reason for the Shortage
American Regent is not currently marketing sodium phosphate injection.[1]
Fresenius Kabi states the reason for the shortage is increased demand.[2]
Pfizer has sodium phosphate injection on shortage due to manufacturing delay.[3]
Estimated Resupply Dates
Fresenius Kabi has sodium phosphate 3 mmol/mL 5 mL and 15 mL vials on back order and the
company estimates a release date of mid- to late-March 2019.[2]
Pfizer has sodium phosphate 3 mmol/mL 15 mL vials on back order and the company estimates a
release date of March 2020.[3]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=227
Thrombin Topical Solution (Bovine)
March 4, 2019
Reason for the Shortage
Pfizer has Thrombin-JMI on shortage due to manufacturing delays.
Recombinant thrombin is not affected by this shortage.
Estimated Resupply Dates
Pfizer has Thrombin-JMI 20,000 unit syringe spray kits on back order and the company estimates a
release date of March 2019. The 5,000 unit epistaxis kits are on back order and the company
estimates a release date of July 2019. The 20,000 unit pump spray kits are on back order and the
company estimates a release date of March 2020. The 5,000 unit vials are available in limited supply.
The 5,000 unit syringe spray kits are on back order and the company estimates a release date of
March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=479
Atropine Sulfate Injection
March 5, 2019
Reason for the Shortage
American Regent had atropine injection on shortage due to market demand.
Amphastar has atropine injection available.
Fresenius Kabi has atropine injection available.
Hikma has atropine injection available.
Pfizer has atropine injection on shortage due to manufacturing delays.
Estimated Resupply Dates
American Regent has atropine 1 mg/mL 1 mL vials available in limited supply.
Pfizer has atropine 0.1 mg/mL 10 mL LifeShield syringes on back order and the company estimates
release dates of March 2019. The 0.1 mg/mL 10 mL Ansyr syringes are on back order and the
company estimates a release date of April 2019. The 0.1 mg/mL 5 mL LifeShield syringes are on back
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order and the company estimates release dates of July 2019. The 0.05 mg/mL 5 mL Ansyr syringes
are available with an expiration date of May 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=46
Cidofovir Injection
March 5, 2019
Reason for the Shortage
Heritage has cidofovir available.
Mylan Institutional did not provide a reason for the shortage.
Estimated Resupply Dates
Mylan Institutional has cidofovir 75 mg/mL 5 mL vials on back order and the company estimates a
release date of mid-May 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=486
Clotrimazole Lozenges (Clotrimazole Troches)
March 5, 2019
Reason for the Shortage
Hikma did not provide a reason for the shortage.
Perrigo has clotrimazole lozenges on shortage due to increased demand.
Estimated Resupply Dates
Hikma has clotrimazole 10 mg lozenges in 70 count and 140 count bottles on allocation. The 10 mg
lozenges in 70 count unit-dose packs are on back order and the company estimates a release date of
early-March 2019.
Perrigo has clotrimazole 10 mg lozenges in 70 count and 140 count bottles on back order and the
company estimates a release date of late-March 2019 for the 70 count bottles and August 2019 for
the 140 count bottles. The 10 mg lozenges in 70 count unit-dose packs are on back order and the
company estimates a release date of August 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=541
Diclofenac 0.1% Ophthalmic Solution
March 5, 2019
Reason for the Shortage
Akorn discontinued diclofenac ophthalmic solution.
Rising pharmaceuticals discontinued diclofenac ophthalmic solution.
Sandoz has diclofenac available.
Estimated Resupply Dates
All marketed presentations are available.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=395
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Hydralazine injection
March 5, 2019
Reason for the Shortage
Akorn has product on back order due to increased demand.
American Regent is not currently marketing hydralazine injection.
Fresenius Kabi did not provide a reason for the shortage.
X-Gen did not provide a reason for the shortage.
Estimated Resupply Dates
Akorn has hydralazine 20 mg/mL 1 mL vials on allocation.
Fresenius Kabi has hydralazine 20 mg/mL 1 mL vials on back order and the company estimates a
release date of mid-March 2019. Check wholesalers for inventory.
X-Gen has hydralazine 20 mg/mL 1 mL vials on intermittent back order and the company is releasing
product as it becomes available.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=431
Hydroxyprogesterone Caproate Injection
March 5, 2019
Reason for the Shortage
AMAG has Makena vials on shortage due to manufacturing delay.
American Regent has hydroxyprogesterone injection available.
Mylan has hydroxyprogesterone injection available.
Prasco has hydroxyprogesterone injection available.
Slayback Pharma launched hydroxyprogesterone injection in January 2019.
Estimated Resupply Dates
AMAG has Makena 250 mg/mL 1 mL and 5 mL vials on back order and the company estimates cannot
estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=501
Hypromellose Ophthalmic Solution
March 5, 2019
Reason for the Shortage
Akorn has hypromellose ophthalmic solution on shortage due to lack of raw materials.1
HUB Pharmaceuticals has hypromellose ophthalmic solution on long-term back order and did not
provide a reason.2
Altaire did not provide a reason for the shortage.[3]
Estimated Resupply Dates
Akorn has Gonak 2.5% ophthalmic solution 15 mL bottles on back order and the company cannot
estimate a release date.1
HUB Pharmaceuticals has Goniovisc 2.5% ophthalmic solution 15 mL bottles on long-term back order
and the company cannot estimate a release date.2
Ocusoft has Goniosoft 2.5% ophthalmic solution 15 mL bottles on back order and the company
cannot estimate a release date.[4]
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Altaire has Goniotaire on back order and the company cannot estimate a release date.[3]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=437
Promethazine Injection
March 5, 2019
Reason for the Shortage
Hikma did not provide a reason for the shortage.
X-Gen has promethazine injection available.
Estimated Resupply Dates
Hikma has promethazine 25 mg/mL 1 mL ampules on back order and the company estimates a
release date of mid- to late-March 2019. The 50 mg/mL 1 mL ampules are on back order and the
company estimates a release date of mid- to late-March 2019.
Hikma has short-dated Phenergan 50 mg/mL 1 mL ampules available with an expiration date of
August 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=460
Thiothixene Capsules
March 5, 2019
Reason for the Shortage
Mylan did not provide a reason for the shortage.
Mylan is the sole supplier of thiothixene.
Estimated Resupply Dates
Mylan has thiothixene 1 mg, 2 mg, 5 mg, and 10 mg capsules in 100 count bottles on back order and
the company estimates a release date of mid-April 2019 for the 1 mg and 5 mg capsules and mid- to
late-March 2019 for the 2 mg and 10 mg capsules.
Mylan Institutional has thiothixene 2 mg, 5 mg, and 10 mg capsules in 100 count unit-dose blister
packs on back order and the company estimates a release date of late-April to early-May 2019 for
the 2 mg and 10 mg capsules and mid- to late-May 2019 for the 5 mg capsules.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=418
Trifluoperazine Tablets
March 5, 2019
Reason for the Shortage
Mylan did not provide a reason for the shortage.
Upsher-Smith did not provide a reason for the shortage.
Estimated Resupply Dates
Mylan has trifluoperazine 1 mg, 2 mg, 5 mg, and 10 mg tablets in 100 count bottles on back order
and the company estimates a release date of early-May 2019 for the 1 mg and 5 mg tablets and
early-April 2019 for the 2 mg and 10 mg tablets. The 1 mg, 2 mg, 5 mg, and 10 mg tablets in 100
count unit-dose packs are on back order and the company estimates a release date of early-June
2019 for the 1 mg and 5 mg tablets and mid-May 2019 for the 2 mg and 10 mg tablets.
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Upsher-Smith has trifluoperazine 1 mg, 2 mg, 5 mg, and 10 mg tablets in 100 count bottles on long-
term back order and the company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=457
0.9% Sodium Chloride 10 mL, 20 mL, and 50 mL Preservative Free Vials and Syringes
March 6, 2019
Reason for the Shortage
Fresenius Kabi has recalled multiple lots of 0.9% sodium chloride 10 mL and 20 mL vials due to labels
incorrectly stating the stoppers are latex-free. The letter and the lot numbers affected can be found
at https://www.fresenius-kabi.com/us/news/fresenius-kabi-issues-voluntary-nationwide-recall-of-
sodium.
Pfizer has 0.9% sodium chloride preservative-free vials on shortage due to manufacturing delays.
Estimated Resupply Dates
Pfizer has 0.9% sodium chloride preservative free 20 mL and 50 mL vials on back order and the
company estimates a release date of April 2019 for the 20 mL vials and March 2019 for the 50 mL
vials. The 10 mL LifeShield syringes are on back order and the company estimates a release date of
March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=332
Alpha-1 Proteinase Inhibitor
March 6, 2019
Reason for the Shortage
CSL Behring states Zemaira is available.
The other alpha-1 proteinase inhibitors such as Aralast and Prolastin-C are not affected by this
shortage.
Estimated Resupply Dates
CSL Behring has Zemaira 1 mg vials available.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=452
Asparaginase Erwinia chrysanthemi
March 6, 2019
Reason for the Shortage
Jazz Pharmaceuticals has Erwinaze available.
Estimated Resupply Dates
Jazz Pharmaceuticals has Erwinaze 10,000 unit vials in 1 count and 5 count available. There is a new
process for ordering Erwinaze. Additional information regarding the new ordering process is
available at www.erwinazesupply.com.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=482
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Dexmedetomidine Hydrochloride 4 mcg/mL Premix for Injection
March 6, 2019
Reason for the Shortage
Pfizer did not provide a reason for the shortage.
WG Critical Care began marketing premixed bags in November 2018.
Baxter has dexmedetomidine premixed bags available.
Estimated Resupply Dates
Pfizer has Precedex 4 mcg/mL 20 mL glass vials and 4 mcg/mL 50 mL and 100 mL premixed bottles
available in limited supply.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=398
Fentanyl Citrate Injection
March 6, 2019
Reason for the Shortage
Akorn has fentanyl injection on shortage due to increased demand. They are not currently marketing
25 count fentanyl ampules.
Hikma has fentanyl injection on shortage due to supply and demand issues. They are not currently
marketing fentanyl ampules, just vials.
Pfizer has fentanyl injection on shortage due to manufacturing delays. The 20 mL ampules were
discontinued in September 2017.
Estimated Resupply Dates
Pfizer has fentanyl 50 mcg/mL 2 mL and 20 mL vials on back order and the company estimates a
release date of March 2019. The 2 mL Carpuject syringes are on back order and the company
estimates a release date of December 2019. The 50 mL vials are available in limited supply and the
company estimates a release date of April 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=315
Haloperidol Tablets
March 6, 2019
Reason for the Shortage
Mylan did not provide a reason for the shortage.
Sandoz has discontinued haloperidol 0.5 mg and 1 mg tablets.
Estimated Resupply Dates
Mylan has haloperidol 0.5 mg and 1 mg tablets in 100 count unit-dose packs on back order and the
company estimates a release date of early-May 2019. The 2 mg and 5 mg tablets are on back order
and the company estimates a release date of mid-May 2019. The 10 mg tablets in 100 count unit-
dose packs are on back order and the company estimates a release date of early-June 2019. The 0.5
mg tablets in 100 count and 1000 count, 1 mg tablets in 100 count and 1000 count, 2 mg tablets in
100 count and 1000 count, and 5 mg tablets in 100 count and 1000 count are on back order and the
company estimates a release date of mid-April 2019. The 10 mg tablets in 100 count and 20 mg
tablets in 100 count are on back order and the company estimates a release date of mid-May 2019.
Zydus has all haloperidol tablet presentations on allocation.
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https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=459
Hydroxyethyl Starch in Sodium Chloride Injection
March 6, 2019
Reason for the Shortage
BBraun did not provide a reason for the shortage of Hespan.
Pfizer has 6% hetastarch in 0.9% sodium chloride injection available.
Pfizer has Voluven available.
Estimated Resupply Dates
BBraun has Hespan injection on intermittent back order and the company is releasing supplies as
they become available.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=454
Metronidazole Hydrochloride Injection
March 6, 2019
Reason for the Shortage
Pfizer has metronidazole injection on shortage due to manufacturing delay.
BBraun has metronidazole injection available.
Estimated Resupply Dates
Baxter has metronidazole 100 mL bags (NDC 36000-0001-24) on back order and the company cannot
estimate a release date.
Pfizer has metronidazole 100 mL bags in 24 count on back order and the company estimates a
release date of March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=316
Mineral Oil and Petrolatum Ophthalmic Ointment
March 6, 2019
Reason for the Shortage
Allergan states the shortage is due to production delays.
Bausch Health has Soothe Night Time ointment available.
Major did not provide a reason for the shortage.
Alcon states the shortage is due to manufacturing issues.
Perrigo discontinued Puralube ointment products in early-2019.
Rugby did not provide a reason for the shortage.
Estimated Resupply Dates
Allergan has Refresh PM and Lacri-Lube SOP ointment 3.5 gram tubes on back order and the
company cannot estimate a release date. Lacri-Lube SOP 7 gram tubes are also on back order and
the company cannot estimate a release date.
Rugby has Artificial Tears 3.5 gram tubes on back order and the company cannot estimate a release
date.
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Alcon has Systane Nighttime ointment and Genteal PM ointment on back order and the company
estimates a release date in early-April 2019 for Systane Nighttime ointment and mid-April 2019 for
Genteal PM ointment.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=435
Nelfinavir Mesylate Tablets
March 6, 2019
Reason for the Shortage
Viiv Healthcare states the shortage is due to a manufacturing issue.
Viiv Healthcare is the sole supplier of nelfinavir.
Estimated Resupply Dates
Viiv Healthcare has Viracept tablets on back order and the company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=543
Potassium Chloride Injection
March 6, 2019
Reason for the Shortage
Baxter had their highly concentrated potassium chloride in sterile water on shortage because a
manufacturing facility was affected by Hurricane Maria. Baxter did not provide a reason for the
shortage of their other potassium chloride products.
Fresenius Kabi did not provide a reason for the shortage.
Pfizer has potassium chloride injection on shortage due to increase demand. Pfizer discontinued 2
mEq/mL 250 mL bottles in mid-2018.
ICU Medical has potassium chloride injection on shortage due to increased demand.
ICU Medical discontinued potassium chloride 10 mEq/500 mL in 5% dextrose and 0.225% sodium
chloride in 2018.
Estimated Resupply Dates
Fresenius Kabi has potassium chloride 10 mEq/5 mL vials on back order and the company estimates a
release date in mid- to late-March 2019.
ICU Medical has all potassium chloride injection presentations available to current customers.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=12
Sincalide Injection
March 6, 2019
Reason for the Shortage
Bracco Diagnostics has Kinevac injection on shortage due to a supply disruption.
There are no approved alternatives to Kinevac for the labeled indications.
Estimated Resupply Dates
Bracco has Kinevac on backorder and the company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=277
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Heparin Sodium Premixed Bags
March 7, 2019
Reason for the Shortage
Baxter has heparin on shortage due to manufacturing delays.
Braun has heparin premixes available.
Fresenius Kabi has heparin premixes available.
Pfizer has heparin on shortage due to manufacturing delays.
Estimated Resupply Dates
Baxter has heparin 2000 units/1,000 mL premixed bags on back order and the company cannot
estimate a release date.
Pfizer has heparin 2,000 units/1,000 mL 0.9% sodium chloride premixed bags on back order and the
company estimates a release date of March 2019. The 25,000 units/250 mL 0.45% sodium chloride
premixed bags and 25,000 units/250 mL 5% dextrose premixed bags are on back order and the
company estimates a release date of March 2019. Heparin 1,000 units/500 mL 0.9% sodium chloride
premixed bags are available in limited supply.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=468
Indomethacin Capsules
March 7, 2019
Reason for the Shortage
Camber did not provide a reason for the shortage.
Glenmark has indomethacin on shortage due to manufacturing delays.
Heritage discontinued all indomethacin presentations in early-2018.
Mylan did not provide a reason for the shortage. Mylan is in the process of discontinuing all
presentations.
Sandoz discontinued indomethacin in mid-2016.
Teva discontinued all indomethacin presentations in mid-2018.
Estimated Resupply Dates
Camber has indomethacin 25 mg and 50 mg capsules on intermittent back order and the company is
releasing product weekly.
Glenmark has indomethacin 25 mg capsules in 100 count and 1,000 count and 50 mg capsules in 100
count and 500 count on back order and the company estimates a release date of late-April to early-
May 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=235
Methyldopa Tablets
March 7, 2019
Reason for the Shortage
Accord did not provide a reason for the shortage.
Mylan did not provide a reason for the shortage.
Teva did not provide a reason for the shortage.
Estimated Resupply Dates
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Accord has temporarily discontinued all methyldopa tablet presentations.
Teva has methyldopa 500 mg tablets temporarily unavailable with no estimated release date.
Mylan has methyldopa 250 mg tablets and 500 mg tablets in 100 count bottles on back order and the
company estimates a release date of early-October 2019. The 250 mg tablets and 500 mg tablets in
100 count unit-dose packs are on back order and the company estimates a release date of late-
October to early-November 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=462
Octreotide Injection
March 7, 2019
Reason for the Shortage
Fresenius Kabi has octreotide available.
Hikma did not provide a reason for the shortage.
Mylan Institutional did not provide a reason for the shortage.
Sagent has octreotide on shortage due to increased demand.
Sun Pharma is not currently marketing octreotide.
Teva did not provide a reason for the shortage.
Novartis has Sandostatin available. The 200 mcg/mL 5 mL vials were discontinued in early-2018.
Estimated Resupply Dates
Hikma has octreotide 1000 mcg/mL 5 mL vials on back order and the company estimates a release
date of March 2019. The 100 mcg/mL 1 mL vials, 500 mcg/mL 1 mL vials, and 200 mcg/mL 5 mL vials
are available with a short expiration date of March 2019.
Mylan has octreotide 100 mcg/mL 1 mL syringe on back order and the company estimates a release
date in early-April 2019.
Novartis has Sandostatin 50 mcg/mL 1 mL ampules available with short expiration dating (September
2019).
Sagent has ocreotide 50 mcg/mL 1 mL vials on back order and the company cannot estimate a
release date. The 100 mcg/mL 1 mL vials are on back order and the company estimates a release
date in June 2019.
Teva has octreotide 100 mcg/mL 1 mL vials on intermittent back order and the company is allocating
product as it becomes available.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=229
Orphenadrine Citrate Injection
March 7, 2019
Reason for the Shortage
Akorn did not provide a reason for the shortage.
Hikma did not provide a reason for the shortage.
Teva discontinued orphenadrine in November 2018.
Estimated Resupply Dates
Akorn has orphenadrine 30 mg/mL 2 mL vials on back order and the company estimates a release
date of March 2019.
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Hikma has orphenadrine 30 mg/mL 2 mL vials on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=471
0.9% Sodium Chloride Large Volume Bags
March 7, 2019
Reason for the Shortage
Baxter discontinued 0.9% sodium chloride 250 mL and 500 mL AVIVA bags. The Viaflex bags and
Viaflo bags are available.[1]
BBraun did not provide a reason for the shortage.[2]
BD has 0.9% sodium chloride bags for injection available.[3]
ICU Medical cited increased demand as the reason for the shortage.[4]
Fresenius Kabi has 0.9% sodium chloride bags for injection available.[9]
Baxter has received FDA approval for 0.9% sodium chloride in Viaflo containers manufactured in an
FDA-approved facility in Spain. Additional information about this product is available at:
http://www.baxter.com/information/saline_supply.html.
Estimated Resupply Dates
ICU Medical has all 0.9% sodium chloride bags readily available except the 0.9% sodium chloride 250
mL 2-port bags are available to current customers only. [4]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=76
0.9% Sodium Chloride Small Volume Bags (< 150 mL)
March 7, 2019
Reason for the Shortage
Baxter did not provide a reason for the 0.9% sodium chloride small volume bags shortage. Most
presentations are available.
BBraun has 0.9% sodium chloride small volume bags available.
BD has 0.9% sodium chloride small volume bags available.
Fresenius Kabi has 0.9% sodium chloride small volume bags available.
ICU Medical has 0.9% sodium chloride small volume bags on shortage due to increased demand.
Pfizer has 0.9% sodium chloride small volume presentations on shortage due to increased demand.
Estimated Resupply Dates
ICU Medical has 0.9% sodium chloride 100 mL VisIV bags on allocation to current customers.
Pfizer has 0.9% sodium chloride 50 mL preservative-free vials on back order and the company
estimates a release date of March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=352
14.6% Sodium Chloride Concentrated Solution for Injection
March 7, 2019
Reason for the Shortage
Pfizer has 14.6% sodium chloride concentrated solution for injection on shortage due to
manufacturing delays.
Estimated Resupply Dates
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Pfizer has 14.6% sodium chloride concentrated solution for injection 20 mL and 40 mL vials on back
order and the company estimates a release date of March 2020 for the 20 mL vials and April 2019 for
the 40 mL vials.
Fresenius Kabi has 14.6% sodium chloride concentrated solution for injection 40 mL vials on back
order and the company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=416
2% Lidocaine Hydrochloride Topical Jelly
March 7, 2019
Reason for the Shortage
Akorn has 2% lidocaine jelly on shortage due to increased demand.
Teva discontinued lidocaine jelly in early-2018.
Glydo and Uro-Jet prefilled syringes are not affected by this shortage.
Estimated Resupply Dates
Akorn has 2% lidocaine jelly 5 mL and 30 mL tubes on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=400
25% Dextrose Injection
March 7, 2019
Reason for the Shortage
Pfizer has 25% dextrose on shortage due to manufacturing delays.
Estimated Resupply Dates
Pfizer has 25% dextrose 10 mL Ansyr syringes on back order and the company estimates a release
date of April 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=483
5% Dextrose Injection (PVC-free and DEHP-free)
March 7, 2019
Reason for the Shortage
Baxter is not currently marketing 5% dextrose PVC/DEHP-free bags.
BBraun had 5% dextrose PVC/DEHP-free bags on shortage due to manufacturing delays.
BD has 5% dextrose PVC/DEHP-free bags available.
Fresenius Kabi has 5% dextrose PVC/DEHP-free bags available.
ICU Medical has 5% dextrose PVC/DEHP-free bags due to manufacturing delays.
Estimated Resupply Dates
ICU Medical has 5% dextose PVC/DEHP-free 50 mL and 250 mL bags on allocation to contracted
customers only.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=314
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50% Dextrose Injection
March 7, 2019
Reason for the Shortage
Amphastar has 50% dextrose injection on allocation due to increased demand.
Pfizer has 50% dextrose injection on shortage due to manufacturing delays.
Estimated Resupply Dates
Pfizer has 50% dextrose 50 mL LifeShield syringes on back order and the company estimates a
release date of June 2019. The 50% dextrose 50 mL Ansyr syringes are on back order and the
company estimates a release date of April 2019. The 50% dextrose 50 mL vials are on back order and
the company estimates a release date of May 2019.
Amphastar has 50% dextrose 50 mL Luer-Jet syringes on allocation with regular releases.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=306
Ascorbic Acid Injection
March 7, 2019
Reason for the Shortage
Mylan Institutional did not provide a reason for the shortage.
Estimated Resupply Dates
Mylan Institutional has ascorbic acid 500 mg/mL 50 mL vials on back order and the company
estimates a release date of mid-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=531
Azithromycin Injection
March 7, 2019
Reason for the Shortage
AuroMedics did not provide a reason for the shortage.
Fresenius Kabi has azithromycin injection on shortage due to increased demand.
Pfizer has azithromycin injection on shortage due to manufacturing delays.
Sun Pharma is not currently manufacturing azithromycin injection.
Estimated Resupply Dates
AuroMedics has azithromycin 500 mg vials on intermittent back order and the company is releasing
product as it becomes available.
Fresenius Kabi has azithromycin 500 mg vials on back order and the company estimates a release
date of mid- to late-March 2019.
Pfizer has azithromycin 500 mg ADD-Vantage vials on back order and the company estimates a
release date of March 2020. Zithromax 500 mg vials are on back order and the company estimates a
release date of March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=380
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Cefoxitin Sodium Injection
March 7, 2019
Reason for the Shortage
Apotex did not provide a reason for the shortage.
BBraun has cefoxitin on allocation due to increased demand.
Fresenius Kabi did not provide a reason for the shortage.
Hikma did not provide a reason for the shortage. Hikma is not currently marketing cefoxitin.
Sagent has cefoxitin on shortage due to increased demand and manufacturing delay.
WG Critical Care did not provide a reason for the shortage.
Estimated Resupply Dates
Apotex has temporarily discontinued cefoxitin 1 gram, 2 gram, and 10 gram vials and the company
cannot estimate when product will be available again.
BBraun has cefoxitin 1 gram and 2 gram DUPLEX bags on back order and the company cannot
estimate a next release date.
Fresenius Kabi has cefoxitin 1 gram and 2 gram vials on back order and the company estimates a
release date of mid-May 2019 for the 1 gram vials and mid-March 2019 for the 2 gram vials.
Sagent has cefoxitin 1 gram and 2 gram vials on back order and the company estimates a release
date of March 2019. The 10 gram vials are on back order and the company estimates a release date
of April 2019.
WG Critical Care has cefoxitin 2 gram vials on back order and the company estimates a release date
of March 2019. The 1 gram vials are on back order and the company estimates a release date of April
2019. The 10 gram vials are on back order and the company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=271
Fluticasone and Salmeterol Powder for Inhalation
March 7, 2019
Reason for the Shortage
Teva Respiratory did not provide a reason for the shortage.
Other fluticasone and salmeterol dry powder inhalers are not affected by the shortage.
Estimated Resupply Dates
Teva Respiratory has AirDuo Respiclick 113 mcg/14 mcg and 232 mcg/14 mcg dry powder inhalers on
back order and the company estimates a release date of early-April 2019.
Teva Respiratory has fluticasone and salmeterol 113 mcg/14 mcg and 232 mcg/14 mcg dry powder
inhalers on back order and the company estimates a release date of late-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=544
Amiodarone Injection
March 8, 2019
Reason for the Shortage
Baxter has Nexterone premixed bags on shortage due to manufacturing delays.
Mylan Institutional did not provide a reason for the shortage.
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Hikma did not provide a reason for the shortage; however, the 50 mg/mL, 3 mL 10 count
presentation was discontinued in December 2018.
Estimated Resupply Dates
AuroMedics has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on intermittent back order and
the company is releasing product as it becomes available.
Baxter has Nexterone 150 mg/100mL and 360 mg/200mL premixed bags on allocation.
Fresenius Kabi has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a
release date of mid-March 2019. There are short-dated 4 mL vials available with an expiration date
of <3 months.
Mylan Institutional has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a
release date of mid-March 2019. The 9 mL vials are on back order and the company cannot estimate
a release date.
Sagent has amiodarone 50 mg/mL 3 mL vials available with a short expiry of February 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=374
Ceftriaxone Sodium Injection
March 8, 2019
Reason for the Shortage
Apotex has ceftriaxone available.
Fresenius Kabi states the reason for the shortage was increased demand.
Pfizer had ceftriaxone injection on shortage due to increased demand and manufacturing delays.
Sagent states the reason for the shortage is manufacturing delay.
Sandoz has ceftriaxone available.
Hikma states the reason for the shortage is manufacturing delay.
Wockhardt has discontinued their ceftriaxone presentations.
Estimated Resupply Dates
Baxter has ceftriaxone premixed bags on back order and the company cannot estimate a release
date.
Lupin has all ceftriaxone presentations on allocation.
Hikma has ceftriaxone 250 mg and 500 mg vials on back order and the company cannot estimate a
release date. The 1 gram and 2 gram vials are on back order and the company estimates a release
date of mid-March 2019.
Sagent has ceftriaxone 1 gram vials on back order and the company estimates a release date in April
2019. There are short-dated 500 mg vials available with an expiration date of April 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=86
Cyclosporine Capsules
March 8, 2019
Reason for the Shortage
Apotex has cyclosporine capsules available.
Sandoz has discontinued cyclosporine (modified) capsules.
Estimated Resupply Dates
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Teva has cyclosporine 25 mg, 50 mg, and 100 mg capsules on intermittent back order and the
company is releasing product as it becomes available.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=476
Immune Globulin, Intravenous or Subcutaneous (Human)
March 8, 2019
Reason for the Shortage
Grifols has Gamunex-C on shortage due to increased market demand.
Takeda has Gammagard Liquid on shortage due to increased demand.
Estimated Resupply Dates
Grifols has all Gamunex-C presentations on intermittent back order and the company is releasing
product as it becomes available.
Takeda has all Gammagard Liquid presentations on intermittent back order and the company is
releasing product as it becomes available.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=527
Piperacillin and Tazobactam Injection
March 8, 2019
Reason for the Shortage
Apotex has piperacillin/tazobactam injection available.
AuroMedics has piperacillin/tazobactam injection available.
Baxter has piperacillin/tazobactam injection available.
Fresenius Kabi has piperacillin/tazobactam injection available.
Mylan Institutional did not provide a reason for the shortage.
Pfizer has Zosyn single dose vials and piperacillin/tazobactam on shortage due to manufacturing
delays.
Sagent has piperacillin/tazobactam injection on shortage due to increased demand.
Sandoz has piperacillin/tazobactam injection available.
WG Critical Care has piperacillin/tazobactam injection available.
Wockhardt has piperacillin/tazobactam injection available.
X-Gen has piperacillin/tazobactam injection available.
Estimated Resupply Dates
Mylan has piperacillin/tazobactam 4.5 gram vials on back order and the company estimates a release
date of mid-May 2019.
Pfizer has Zosyn 2.25 gram vials, 3.375 gram vials, 4.5 gram vials, and 40.5 gram vials on back order
and the company estimates a release date of March 2020. The piperacillin/tazobactam 2.25 gram
ADD-Vantage vials are on back order and the company estimates a release date of July 2019. The
3.375 gram vials are available in limited supply.
Sagent has piperacillin/tazobactam 3.375 gram and 4.5 gram vials on back order and the company
estimates a release date of April 2019. There are short-dated 2.25 gram vials available with an
expiration date of October 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=158
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Thiamine Injection
March 8, 2019
Reason for the Shortage
Fresenius Kabi has thiamine injection on shortage due to short manufacturing delay.
Mylan Institutional has thiamine injection available.
Estimated Resupply Dates
Fresenius Kabi has thiamine 100 mg/mL 2 mL vials on back order and the company estimates a
release date of late-March 2019.
Mylan Institutional has thiamine 100 mg/mL 2 mL vials on back order and the company estimates a
release date of mid-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=502
Tobramycin Sulfate Injection
March 8, 2019
Reason for the Shortage
Akorn discontinued tobramycin injection in late-2018.
Pfizer had tobramycin injection on shortage due to manufacturing delays.
Teva discontinued tobramycin 40 mg/mL 30 mL vials in June 2018.
Estimated Resupply Dates
Baxter (formerly Claris) has tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the
company cannot estimate a release date.
Mylan Institutional has tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the company
estimates a release date of mid-April 2019.
Pfizer has tobramycin 40 mg/mL 2 mL vials available in limited supply.
Teva has temporarily discontinued tobramycin 40 mg/mL 2 mL vials.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=164
Amphotericin B Injection
March 11, 2019
Reason for the Shortage
X-Gen has amphotericin B on shortage due to manufacturing delays. They are the sole suppliers of
amphotericin B lyophilized powder for injection.[1]
Lipid-based amphotericin is not affected by this shortage.
Estimated Resupply Dates
X-Gen has amphotericin B 50 mg vials on back order and the company estimates a release date of
mid-April 2019.[1]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=524
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Benztropine Mesylate Injection
March 11, 2019
Reason for the Shortage
Akorn did not provide a reason for the shortage.
Fresenius Kabi did not provide a reason for the shortage.
Hikma did not provide a reason for the shortage.
Estimated Resupply Dates
Akorn has benztropine 1 mg/mL 2 mL ampules and Cogentin 1 mg/mL 2 mL ampules on back order
and the company cannot estimate a release date.
Fresenius Kabi has benztropine 1 mg/mL 2 mL vials on back order and the company estimates a
release date of mid- to late-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=497
Betamethasone Acetate/Betamethasone Sodium Phosphate Suspension for Injection
March 11, 2019
Reason for the Shortage
American Regent has betamethasone acetate/betamethasone sodium phosphate on shortage due to
minor shipping delays.
Merck did not provide a reason for the shortage.
Exela Pharma Sciences has betamethasone acetate/betamethasone sodium phosphate on shortage
due to increased demand.
Estimated Resupply Dates
American Regent has betamethasone acetate/betamethasone sodium phosphate 6 mg/mL 5 mL vials
available in limited supply.
Exela has betamethasone acetate/betamethasone sodium phosphate 6 mg/mL 5 mL vials on back
order and the company estimates a release date of early- to mid-April 2019.
Merck has Celestone Soluspan 5 mL vials on back order and the company estimates a release date of
April 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=485
Bupivacaine with Epinephrine Injection
March 11, 2019
Reason for the Shortage
Fresenius Kabi has bupivacaine and epinephrine on shortage due to increased demand and
manufacturing delays.
Pfizer has bupivacaine with epinephrine on shortage due to manufacturing delays.
Estimated Resupply Dates
Fresenius Kabi has 0.25% Sensorcaine-MPF with epinephrine 10 mL vials on back order and the
company estimates a release date of late-March 2019. The 0.25% Sensorcaine-MPF with epinephrine
30 mL vials are on back order and the company estimates a release date of mid- to late-March 2019.
The 0.25% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a
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200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
release date of mid- to late-March 2019. The 0.5% Sensorcaine-MPF with epinephrine 30 mL sterile
packs are on back order and the company cannot estimate a release date.
Pfizer has 0.25% bupivacaine with epinephrine 10 mL and 30 mL preservative-free vials on back
order and the company estimates a release date of September 2019. The 0.25% bupivacaine with
epinephrine 50 mL vials are on back order and the company estimates a release date of September
2019. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and
the company estimates a release date of September 2019. The 0.5% bupivacaine with epinephrine
30 mL preservative-free vials are on back order and the company estimates a release date of April
2019.The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company
estimates a release date of September 2019.
Pfizer has 0.25% Marcaine with epinephrine 30 mL preservative-free vials on back order and the
company estimates a release date of September 2019. The 0.25% Marcaine with epinephrine 10 mL
preservative-free vials are on back order and the company estimates a release date of March 2020.
The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a
release date of September 2019. The 0.5% Marcaine with epinephrine 10 mL and 30 mL
preservative-free vials are on back order and the company estimates a release date of March 2020.
The 0.5% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a
release date of September 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=261
Butorphanol Tartrate Injection
March 11, 2019
Reason for the Shortage
Pfizer has butorphanol injection on shortage due to manufacturing delays.
Estimated Resupply Dates
Pfizer has butorphanol 1 mg/mL 1 mL vials on back order and the company estimates a release date
of April 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=414
Calcium Chloride Injection
March 11, 2019
Reason for the Shortage
American Regent has calcium chloride injection available.
Amphastar has calcium chloride injection available.
Pfizer has calcium chloride on shortage due to manufacturing delays.
Mylan Institutional has withdrawn calcium chloride syringes from the market. The company recalled
the syringes in April 2015 due to incompatibility of the syringes and some needless adaptors.
Estimated Resupply Dates
Pfizer has calcium chloride 100 mg/mL 10 mL Ansyr syringes available in limited supply. The 100
mg/mL 10 mL LifeShield syringes are on back order and the company estimates a release date of
March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=48
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Calcium Gluconate Injection
March 11, 2019
Reason for the Shortage
American Regent is not currently marketing calcium gluconate.
Fresenius Kabi has calcium gluconate available.
WG Critical Care launched calcium gluconate premixed bags in January 2019.
Estimated Resupply Dates
Fresenius Kabi has calcium gluconate 100 mg/mL 100 mL vials on back order and the company
estimates a release date of mid- to late-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=150
Cefazolin Injection
March 11, 2019
Reason for the Shortage
Apotex has discontinued all presentations except cefazolin 1 gram vials.
Baxter did not provide a reason for the shortage.
BBraun has cefazolin on shortage due to manufacturing delays.
Fresenius Kabi has cefazolin on shortage due to increased demand. They are not manufacturing the
20 gram vials at this time to focus on the other sizes.
Pfizer states the reason for the shortage is manufacturing delay.
Sagent states the reason for the shortage is manufacturing delays and increased demand.
Samson Medical Technologies has cefazolin injection available.
Sandoz has cefazolin injection available.
Hikma did not provide a reason for the shortage.
WG Critical Care did not provide a reason for the shortage.
Estimated Resupply Dates
Baxter has cefazolin 2 gram/100 mL premixed bags on allocation.
BBraun has 1 gram/50 mL and 2 gram/50 mL premixed bags on allocation.
Fresenius Kabi has cefazolin 500 mg vials on back order and the company estimates a release date of
mid- to late-March 2019. The 1 gram vials are on back order and the company estimates a release
date of late-April 2019. The 10 gram vials are on back order and the company estimates a release
date of 2nd quarter 2019.
Pfizer has 1 gram and 10 gram vials on back order and the company estimates a release date of
September 2019. The 1 gram ADD-Vantage vials are on back order and the company estimates a
release date of June 2019.
Sagent has cefazolin 500 mg and 10 gram vials on back order and the company cannot estimate a
release date. The 1 gram vials are on back order and the company estimates a release date of April
2019.
Hikma has cefazolin 500 mg vials on back order and the company estimates a release date of April to
May 2019. The 1 gram and 10 gram vials are on allocation.
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WG Critical Care has cefazolin 500 mg vials on back order and the company cannot estimate a
release date. The 1 gram vials are on intermittent back order with regular releases. The 10 gram vials
are on back order and the company estimates a release date of late-April 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=432
Diltiazem Hydrochloride Injection
March 11, 2019
Reason for the Shortage
Akorn states the reason for the shortage was increased demand due to market conditions. They are
not currently producing the 25 mL vials in 10 count.
Pfizer states the reasons for the shortage is manufacturing delays and increases in demand.
Hilkma has diltiazem injection on shortage due to manufacturing delays caused by increased demand
due to current market conditions.
Estimated Resupply Dates
Akorn has diltiazem 5 mg/mL 5 mL, 10 mL, and 25 mL vials on allocation.
Hikma has diltiazem 5 mg/mL 25 mL vials on allocation.
Pfizer has 100 mg ADD-Vantage vials on back order and the company estimates a release date of
June 2019. The 5 mg/mL 5 mL and 10 mL vials are also on back order and the company estimates a
release date of March 2020 for the 5 mL vials and August 2019 for the 10 mL vials.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=26
Etomidate Injection
March 11, 2019
Reason for the Shortage
American Regent is not currently marketing etomidate.
AuroMedics has etomidate available.
Hikma has etomidate available.
Mylan did not provide a reason for the current shortage.
Par Sterile Products discontinued etomidate in early 2015.
Pfizer has Amidate on shortage due to manufacturing delays. Pfizer discontinued etomidate ampules
in October 2016.
Sagent is no longer marketing etomidate.
Zydus has etomidate available.
Estimated Resupply Dates
AuroMedics has etomidate 2 mg/mL 10 mL and 20 mL vials on intermittent back order and the
company is releasing product as it becomes available.
Pfizer has Amidate 2 mg/mL 20 mL LifeShield syringes on back order and the company estimates a
release date of March 2020.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=147
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Famotidine Injection
March 11, 2019
Reason for the Shortage
Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.[1]
Hikma did not provide a reason for the shortage.[2]
Pfizer launched famotidine injections in March 2012.[3]
Mylan Institutional acquired famotidine injections from Pfizer on December 6, 2013.[4]
Fresenius Kabi did not provide a reason for the shortage.[5]
Baxter did not provide a reason for the shortage.[6]
Estimated Resupply Dates
Baxter has famotidine 20 mg/50 mL premixed bags on back order and the company cannot estimate
a release date.[6]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=166
Leucovorin Calcium Injection
March 11, 2019
Reason for the Shortage
Fresenius Kabi had leucovorin on shortage due to manufacturing delays and increased demand.
Hikma did not provide a reason for the current shortage.
Sagent has leucovorin on shortage due to manufacturing delays.
Teva has leucovorin available.
Estimated Resupply Dates
Hikma has leucovorin 200 mg and 350 mg vials on back order and the company estimates a release
date of April to May 2019 for the 350 mg vials and cannot estimate a release date for the 200 mg
vials.
Sagent has leucovorin 200 mg and 500 mg vials on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=35
Mannitol Injection
March 11, 2019
Reason for the Shortage
American Regent is not currently marketing mannitol.
Baxter did not provide a reason for the mannitol shortage.
BBraun has mannitol 500 mL premixed bags available. The 250 mL premixed bags were discontinued.
Fresenius Kabi had mannitol on shortage due to increased demand.
Pfizer has mannitol on shortage due to manufacturing delays.
Estimated Resupply Dates
Fresenius Kabi has mannitol 250 mg/mL 50 mL vials on back order and the company estimates a
release date of mid- to late-March 2019.
Pfizer has mannitol 250 mg/mL 50 mL vials available in limited supply.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=341
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Morphine Sulfate Immediate-Release Tablets
March 11, 2019
Reason for the Shortage
Hikma did not provide a reason for the shortage.
Estimated Resupply Dates
Hikma has all morphine immediate-release tablets on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=504
Rocuronium Injection
March 11, 2019
Reason for the Shortage
Athenex has rocuronium available.
AuroMedics did not provide a reason for the shortage.
Fresenius Kabi has rocuronium available.
Mylan Institutional did not provide a reason for the shortage.
Pfizer has rocuronium on shortage due to manufacturing delays.
Sagent has rocuronium available.
Sandoz has rocuronium available.
X-Gen has rocuronium available.
Estimated Resupply Dates
AuroMedics has rocuronium 10 mg/mL 5 mL and 10 mL vials on intermittent back order and the
company is releasing product as it becomes available.
Fresenius Kabi has rocuronium 10 mg/mL 5 mL vials on back order and the company estimates a
release date of mid- to late-March 2019.
Mylan Institutional has rocuronium 10 mg/mL 10 mL vials on back order and the company cannot
estimate a release date.
Pfizer has rocuronium 10 mg/mL 5 mL vials available in limited supply. The 10 mL vials are on back
order and the company estimates a release date of March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=290
BCG Live Intravesical
March 12, 2019
Reason for the Shortage
Because of increased global demand, and as the only source of BCG Live (Intravesical) in the United
States and many other countries, Merck anticipates supply constraints for Tice BCG in 2019. To
minimize disruption to patient care and address the current imbalance between supply and
increased global demand, Tice BCG will be under allocation when demand exceeds production plans
and available inventory.
Estimated Resupply Dates
Merck has Tice BCG on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=519
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Busulfan Injection
March 12, 2019
Reason for the Shortage
American Regent did not provide a reason for the shortage.
Amneal did not provide a reason for the shortage.
Sagent has busulfan on shortage due to increased demand.
Estimated Resupply Dates
American Regent has busulfan 6 mg/mL 10 mL vials available in limited supply.
Amneal has busulfan 6 mg/mL 10 mL vials on back order and the company cannot estimate a release
date.
Mylan has busulfan 6 mg/mL 10 mL vials on back order and the company estimates a release date of
April 2019. Short dated (February 2020) vials are available.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=509
Carbidopa and Levodopa Extended-Release Tablets
March 12, 2019
Reason for the Shortage
Accord has discontinued carbidopa and levodopa 25 mg/100 mg extended-release tablets. The 50
mg/200 mg tablets are on shortage due to problems obtaining active ingredient.
Sun Pharma had carbidopa and levodopa extended-release tablets on shortage due to increased
demand.
Merck had Sinemet CR on shortage due to increased demand.
Mylan did not provide a reason for the carbidopa and levodopa extended-release tablet shortage.
Estimated Resupply Dates
Accord has carbidopa and levodopa 50 mg/200 mg extended-release tablets on allocation.
Mylan has carbidopa and levodopa 25 mg/100 mg extended-release tablets in 100 count unit-dose
packs on back order and the company cannot estimate a release date. The carbidopa and levodopa
50 mg/200 mg extended-release tablets in 100 count unit-dose packs are on back order and the
company estimates a release date of mid-May 2018. The 50 mg/200 mg extended release tablets in
100 count bottles are on back order and the company estimates a release date of early-April 2019.
The 25 mg/100 mg extended release tablets in 100 count bottles are on back order and the company
estimates a release date of late-May 2019.
Merck has Sinemet CR 25 mg/100 mg extended release tablets in 100 count bottles on back order
and the company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=349
Cyclosporine Injection
March 12, 2019
Reason for the Shortage
Novartis has Sandimmune available.
Perrigo did not provide a reason for the shortage.
Estimated Resupply Dates
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Perrigo has cyclosporine 50 mg/mL ampules on back order and the company estimates a release
date of mid-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=534
Diltiazem Extended-Release Capsules (Twice-Daily Dosing)
March 12, 2019
Reason for the Shortage
Mylan did not provide a reason for the shortage.
Estimated Resupply Dates
Mylan has diltiazem extended-release 60 mg, 90 mg, and 120 mg capsules in 100 count bottles on
back order and the company estimates a release date of mid-March 2019.
Mylan Institutional has diltiazem extended-release 60 mg, 90 mg, and 120 mg capsules in 100 count
unit-dose packs on back order and the company estimates a release date of late-April to early-May
2019 for the 60 mg capsules and mid- to late-March 2019 for the 90 mg and 120 mg tablets.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=496
Fluorouracil Injection
March 12, 2019
Reason for the Shortage
Accord did not provide a reason for the shortage.
Fresenius Kabi did not provide a reason for the shortage.
Sagent has fluorouracil injection on shortage due to increased demand.
Teva had fluorouracil injection on allocation due to increased demand.
Estimated Resupply Dates
Fresenius Kabi has fluorouracil 50 mg/mL 100 mL vials on back order and the company estimates a
release date of mid-March 2019.
Sagent has fluorouracil 50 mg/mL 100 mL vials on back order and the company estimates a release
date of March 2019.
Teva has fluorouracil 50 mg/mL 100 mL vials on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=401
Methotrexate Injection
March 12, 2019
Reason for the Shortage
Accord has methotrexate injection on back order due to increased demand.[1]
Fresenius Kabi has methotrexate injection available.[2]
Mylan Institutional has methotrexate injection available. Mylan Institutional discontinued the 40
mg/mL 2 mL, 4 mL, and 8 mL vials in late-2017.[3]
Pfizer did not provide a reason for the shortage.[4]
Teva has methotrexate injection on shortage due to increased demand.[5]
Hikma has methotrexate injection available.[6]
Estimated Resupply Dates
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Accord has methotrexate 25 mg/mL 2 mL and 40 mL preservative-free vials on back order and the
company estimates a release date of mid- to late-March 2019.
Mylan Institutional has methotrexate 25 mg/mL 40 mL preservative-free vials on back order and the
company estimates a release date of mid-March 2019.
Teva has methotrexate 25 mg/mL 40 mL preservative-free vials on allocation. Check wholesaler for
inventory.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=282
Mupirocin Calcium 2% Cream
March 12, 2019
Reason for the Shortage
GlaxoSmithKline is looking for an alternative supply source.
Glenmark did not provide a reason for the shortage.
Prasco discontinued mupirocin calcium 2% cream in February 2016.
Estimated Resupply Dates
GlaxoSmithKline has Bactroban 2% cream in 15 gram and 30 gram sizes on long-term back order and
the company cannot estimate a release date.
Glenmark has mupirocin 2% cream in 15 gram tubes on back order and the company cannot
estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=162
Mupirocin Calcium 2% Nasal Ointment
March 12, 2019
Reason for the Shortage
GlaxoSmithKline states the shortage is due to manufacturing issues. GlaxoSmithKline is looking for an
alternative supply source.[1]
Estimated Resupply Dates
GlaxoSmithKline has Bactroban Nasal 2% Ointment in 1 gram tubes on long-term back order and the
company cannot estimate a release date.[1]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=148
Nelarabine Injection
March 12, 2019
Reason for the Shortage
Novartis did not provide a reason for the shortage.
Estimated Resupply Dates
Novartis has Arranon 5 mg/mL 50 mL vials on a limited allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=458
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Prednisolone Acetate 1% Ophthalmic Suspension
March 12, 2019
Reason for the Shortage
Allergan did not provide a reason for the shortage.
Greenstone did not provide a reason for the shortage.
Novartis discontinued Omnipred 1% in 2018.
Sandoz has prednisolone acetate on shortage due to increased demand.
Estimated Resupply Dates
Allergan Pred Forte in 5 mL and 10 mL on back order and the company estimates a release date of
late-March to early-April 2019.
Greenstone has all prednisolone acetate 1% presentations on back order and the company estimates
a release date of mid- to late-March 2019.
Sandoz has prednisolone acetate 1% 10 mL and 15 mL bottles on back order and the company
estimates a release date of mid-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=536
RimabotulintoxinB Intramuscular Injection
March 12, 2019
Reason for the Shortage
Solstice Neurosciences, Inc. did not provide a reason for the shortage.
Estimated Resupply Dates
Solstice Neurosciences, Inc. has Myobloc 5000 unit/mL 0.5 mL vials on back order and the company
cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=526
Argatroban Injection
March 13, 2019
Reason for the Shortage
AuroMedics has argatroban available.
Chiesi has argatroban available.
Fresenius Kabi did not provide a reason for the shortage.
Hikma did not provide a reason for the shortage.
Mylan Institutional did not provide a reason for the shortage.
Par did not provide a reason for the shortage.
Pfizer had argatroban on shortage due to manufacturing delay.
Sandoz did not provide a reason for the shortage.
Teva has argatroban temporarily unavailable.
Estimated Resupply Dates
Fresenius Kabi has argatroban 100 mg/mL 2.5 mL vials on back order and the company estimates a
release date in mid-April 2019.
Hikma has argatroban 1 mg/mL 50 mL vials on allocation.
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Mylan has argatroban 100 mg/mL 2.5 mL vials on back order and the company estimates a release
date in mid-May 2019.
Par has argatroban 100 mg/mL 2.5 mL vials on back order and the company cannot estimate a
release date.
Novartis has argatroban 100 mg/mL 2.5 mL vials available with short expiration dating (November
2019).
Sandoz has argatroban 1 mg/mL 50 mL vials on back order and the company cannot estimate a
release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=494
Buprenorphine Hydrochloride Injection
March 13, 2019
Reason for the Shortage
Pfizer has buprenorphine injection on shortage due to manufacturing delays.
Par had buprenorphine injection on shortage due to increased demand.
Estimated Resupply Dates
Pfizer has buprenorphine 0.3 mg/mL 1 mL Carpuject syringes on back order and the company
estimates a release date of June 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=419
Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution
March 13, 2019
Reason for the Shortage
Akorn has dorzolamide and timolol ophthalmic solution on shortage due to manufacturing delays.
Sandoz did not provide a reason for the shortage.
Teva discontinued dorzolamide and timolol ophthalmic solution in April 2018.
Bausch Health has dorzolamide and timolol ophthalmic solution on shortage due to manufacturing
delays.
Estimated Resupply Dates
Akorn has Cosopt 2%/0.5% ophthalmic solution in 10 mL bottles on back order and the company
cannot estimate a release date. Dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL
bottles are available on allocation.
Bausch Health has dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL bottles on back
order and the company estimates a release date of mid-March 2019.
Sandoz has dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL bottles on back order and
the company estimates a release date of late-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=360
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Dorzolamide Ophthalmic Solution
March 13, 2019
Reason for the Shortage
Akorn has dorzolamide ophthalmic solution on shortage due to manufacturing delays.
Merck did not provide a reason for the shortage.
Sandoz did not provide a reason for the shortage.
Teva discontinued dorzolamide ophthalmic solution in April 2018.
Bausch Health had dorzolamide ophthalmic solution on shortage due to manufacturing delays.
Estimated Resupply Dates
Akorn has dorzolamide 2% ophthalmic solution in 10 mL bottles on allocation.
Sandoz has dorzolamide 2% ophthalmic solution in 10 mL bottles on back order and the company
estimates a release date of early-April 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=359
Guanfacine Hydrochloride Tablets
March 13, 2019
Reason for the Shortage
Amneal did not provide a reason for the shortage.
Mylan did not provide a reason for the shortage.
Teva did not provide a reason for the shortage.
Estimated Resupply Dates
Mylan has guanfacine 1 mg and 2 mg tablets in 100 count bottles on back order and the company
estimates a release date of mid- to late-August 2019.
Teva has guanfacine 1 mg and 2 mg tablets in 100 count bottles on back order and the company
estimates a release date of mid-April 2019 and late-May 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=508
Polyvinyl Alcohol (Artificial Tears) Ophthalmic Solution
March 13, 2019
Reason for the Shortage
Akorn did not provide a reason for the shortage.
Altaire is not currently marketing polyvinyl alcohol 1.4% ophthalmic solution.
Major has polyvinyl alcohol 1.4% ophthalmic solution available.
Ocusoft has polyvinyl alcohol 1.4% ophthalmic solution available.
Rugby has polyvinyl alcohol 1.4% ophthalmic solution available.
Estimated Resupply Dates
Akorn has Artificial Tears Solution ophthalmic drops on back order and the company cannot estimate
a release date.
Major has Liquitears ophthalmic drops on back order and the company cannot estimate a release
date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=451
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Proparacaine Hydrochloride Ophthalmic Solution
March 13, 2019
Reason for the Shortage
Akorn, Bausch Health, and Sandoz did not provide a reason for the shortage.
Estimated Resupply Dates
Akorn has proparacaine 0.5% ophthalmic drops on allocation.
Bausch Health has proparacaine 0.5% ophthalmic drops on back order and the company estimates a
release date of mid- to late-March 2019.
Sandoz has proparacaine 0.5% ophthalmic drops on back order and the company estimates a release
date in late-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=489
Rosuvastatin Calcium Tablets
March 13, 2019
Reason for the Shortage
Accord, Biocon, Glenmark, Mylan, Sandoz, and Rising did not provide a reason for the shortage.
Apotex has discontinued production of all rosuvastatin presentations.
Mylan has discontinued all rosuvastatin presentations.
Sun Pharma will be discontinuing production of all rosuvastatin presentations.
Estimated Resupply Dates
Accord has rosuvastatin 5 mg tablets in 90 count, 5 mg tablets in 1,000 count, 20 mg tablets in 1,000
count, and 40 mg tablets in 30 count on back order and the company estimates a release date of
mid- to late-March 2019. The 10 mg tablets in 1,000 count bottles are on back order and the
company estimates a release date of late-March 2019. The 40 mg tablets in 1,000 count bottles are
on back order and the company estimates release dates of early- to mid-April 2019.
Biocon has rosuvastatin 40 mg tablets in limited supply.
Rising has all rosuvastatin presentations on back order and the company estimates release dates of
late-March 2019.
Sandoz has rosuvastatin 10 mg tablets in 90-count bottles on back order and the company estimates
a release date of early-April 2019.
Sun Pharma will be discontinuing production of rosuvastatin 5 mg, 10 mg, 20 mg, and 40 mg tablets
in 90 count bottles.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=473
Amphetamine Mixed Salts, Immediate-Release Tablets
March 14, 2019
Reason for the Shortage
Aurobindo did not provide a reason for the shortage.
Mallinckrodt has amphetamine mixed salts available.
Mylan did not provide a reason for the shortage.
Sun Pharma did not provide a reason for the shortage.
Teva has Adderall and amphetamine mixed salts available.
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Zydus has amphetamine mixed salts available.
Estimated Resupply Dates
Aurobindo has amphetamine mixed salts, immediate-release 10 mg tablets on back order and the
company cannot estimate a release date.
Mylan has all amphetamine mixed salts, immediate-release tablets on back order and the company
estimates a release date of late-June 2019.
Sun Pharma has amphetamine mixed salts, immediate-release 10 mg tablets available in limited
supply. The 15 mg tablets are available in limited supply as short-dated product (June 2019). All
other strengths are on back order and the company cannot estimate a release date.
Zydus has all amphetamine mixed salts, immediate-release tablets available on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=535
Deferoxamine Injection
March 14, 2019
Reason for the Shortage
Fresenius Kabi had deferoxamine on shortage due to increased demand.
Pfizer has deferoxamine on shortage due to manufacturing delays.
Novartis has Desferal available.
Alvogen launched deferoxamine injection in mid-2018.
Apo-Pharma launched deferoxamine injection in mid-2018.
Estimated Resupply Dates
Pfizer has deferoxamine 500 mg vials on back order and the company estimates a release date of
June 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=393
Dicyclomine Oral Presentations
March 14, 2019
Reason for the Shortage
Hikma did not provide a reason for the shortage.
Lannett did not provide a reason for the shortage.
Mylan did not provide a reason for the shortage.
Par Pharmaceuticals has dicyclomine oral solution available.
Teva did not provide a reason for the shortage.
Estimated Resupply Dates
Hikma has 10 mg capsules in 100 and 1,000 count bottles and 20 mg tablets in 100 and 1,000 count
bottles on available on allocation.
Lannett has 20 mg tablets in 1,000 count bottles on back order and the company estimates a release
date of March 2019.
Mylan has 10 mg capsules in 100 and 500 count bottles on back order and the company estimates a
release date of early- to mid-April 2019. The 20 mg tables in 100 and 500 count bottles are on back
order and the company estimates a release date of mid-April 2019.
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Mylan Institutional has 10 mg capsules and 20 mg tablets on back order and the company estimates
a release date of mid-May 2019.
Teva has 20 mg tablets in 1,000 count bottles on back order and the company estimates a release
date of late-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=521
Epinephrine Auto-Injectors
March 14, 2019
Reason for the Shortage
Amneal has discontinued Adrenaclick. Amneal acquired Impax in 2018.
Mylan had EpiPen on shortage due to supply constraints.
Sandoz launched Symjepi in January 2019 and product is available.
Teva has FDA approval for generic epinephrine.
Estimated Resupply Dates
Amneal has epinephrine 0.15 mg/0.15 mL and 0.3 mg/0.3 mL auto-injectors on allocation.
Teva has epinephrine 0.3 mg/0.3 mL auto injectors on back order and the company cannot estimate
a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=420
Melphalan Tablets
March 14, 2019
Reason for the Shortage
Apo-Pharma did not provide a reason for the shortage.
Estimated Resupply Dates
Apo-Pharma has melphalan 2 mg tablets on long-term back order and the company cannot estimate
a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=472
Meperidine Hydrochloride Injection
March 14, 2019
Reason for the Shortage
Pfizer has Demerol injection on shortage due to manufacturing delays.
ICU Medical discontinued meperidine 30 mL PCA vials.
Estimated Resupply Dates
Hikma has meperidine 50 mg/mL 1 mL vials on back order and the company estimates a release date
of April to May 2019.
Pfizer has Demerol 100 mg/mL 20 mL vials and on back order and the company estimates a release
date of March 2020. The 25 mg/mL 1 mL Carpuject syringes and 50 mg/mL 1 mL Carpuject syringes
are on back order and the company estimates a release date of December 2019. The 75 mg/mL 1 mL
Carpuject syringes and 100 mg/mL 1 mL Carpuject syringes are on back order and the company
estimates a release date of December 2019. The 50 mg/mL 30 mL vials are on back order and the
company estimates a release date of June 2019.
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200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=347
Remifentanil Injection
March 14, 2019
Reason for the Shortage
Mylan Institutional did not provide a reason for the shortage.
Fresnius Kabi launched generic remifentanil in January 2018.
Estimated Resupply Dates
Mylan Institutional has Ultiva 1 mg vials on back order and the company cannot estimate a release
date.
Fresenius Kabi has remifentanil 2 mg and 5 mg vials on back order and the company cannot estimate
a release date. The 1 mg vials are on back order and the company estimates a release date of early-
April 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=371
Sodium Polystyrene Sulfonate Oral or Rectal Suspension
March 14, 2019
Reason for the Shortage
CMP Pharma reports that increased demand has led to a shortage of raw material required to
manufacture the products.
Perrigo has temporarily discontinued their Kionex suspension and sodium polystyrene sulfonate
(sorbitol-free) suspension. They cannot estimate when these products will be manufactured again.
Hikma is not currently marketing sodium polystyrene sulfonate suspension.
Estimated Resupply Dates
CMP Pharma has SPS suspension on intermittent back order and the company is releasing supplies as
they become available.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=430
Testosterone Enanthate Intramuscular Injection
March 14, 2019
Reason for the Shortage
Hikma did not provide a reason for the shortage.
Teva did not provide a reason for the shortage.
Estimated Resupply Dates
Teva has testosterone enanthate 200 mg/mL 5 mL vials temporarily unavailable with no estimated
release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=498
Buspirone Tablets
March 15, 2019
Reason for the Shortage
Accord did not provide a reason for the shortage.
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Mylan did not provide a reason for the shortage.
Teva did not provide a reason for the shortage.
Estimated Resupply Dates
Accord has all buspirone presentations on allocation.
Mylan Institutional has buspirone 5 mg, 10 mg, 15 mg, and 30 mg tablets in 100 count unit-dose
packs on back order and the company cannot estimate a release date.
Mylan has all buspirone presentations in bottles on long-term back order and the company cannot
estimate a release date.
Teva has buspirone 30 mg tablets in 60 and 180 count available in limited supply.
Zydus has all buspirone presentations on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=465
Cefuroxime Sodium Injection
March 15, 2019
Reason for the Shortage
Sagent has cefuroxime injection on shortage due to manufacturing delays.
Teligent discontinued all Zinacef presentations in February 2018.
Hikma did not provide a reason for the cefuroxime injection shortage. They are not currently
marketing the 7.5 gram vials.
Estimated Resupply Dates
Sagent has cefuroxime 750 mg and 1.5 gram vials on back order and the company cannot estimate a
release date.
Hikma has cefuroxime 750 mg and 1.5 gram vials on back order and the company estimates a release
date of late-March to early-April 2019 for the 750 mg vials and late-March 2019 for the 1.5 gram
vials.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=13
Doxorubicin Injection
March 15, 2019
Reason for the Shortage
Hikma did not provide a reason for the shortage of Adriamycin.[1]
Teva had doxorubicin solution for injection on shortage due to increased demand. They discontinued
doxorubicin presentations with NDCs starting in 00703 in early-January 2019.[2-3]
Fresenius Kabi did not provide a reason for the shortage.[4]
Caraco has discontinued doxorubicin solution for injection 25 mL and 100 mL vials.[5]
Pfizer has doxorubicin on shortage due to manufacturing delays.[6]
Sagent discontinued doxorubicin solution for injection in late-2017.[7]
Mylan Institutional did not provide a reason for the shortage of doxorubicin lyophilized powder for
injection.[8]
Athenex has doxorubicin available.[9]
FDA was allowing temporary importation of doxorubicin lyophilized powder for injection 50 mg vials.
These vials were manufactured for Hospira UK Limited. The labeling as well as bar coding for the
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imported product is different from the US version. FDA has the Dear Healthcare Professional Letter
linked on their website. The letter includes a link to both the US and United Kingdom package inserts
to help explain the differences in labeling and packaging. The link to the letter is
http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM507498.pdf. Ordering can be
done directly with Hospira Customer Care at 877-946-7747.[10-11]
Estimated Resupply Dates
Athenex has doxorubicin 2 mg/mL 25 mL vials on back order and the company cannot estimate a
release date. The 100 mL vials have short expiration dating of April 2019.9
Fresenius Kabi has doxorubicin 25 mL vials available with short-expiration dating (< 6 months).[4]
Hikma has Adriamycin 25 mL vials are on back order and the company estimates a release date of
late-March 2019. There are short-dated 2 mg/mL 10 mL vials available with an expiration date of
June 2019. The 50 mg vials are on back order and the company estimates a release date of late-
March 2019. [1]
Mylan Institutional has doxorubicin lyophilized powder 10 mg vials on back order and the company
cannot estimate a release date. The 50 mg vials are on back order and the company estimates a
release date of early-April 2019.[8]
Pfizer has doxorubicin 2 mg/mL 5 mL vials available in limited supply.[6]
Sagent has doxorubicin 2 mg/mL 5 mL, 10 mL, and 25 mL vials on back order and the company
estimates a relaunch date of March 2019.7
Teva has doxorubicin 2 mg/mL 10 mL vials on intermittent back order and the company is allocating
product upon release.[2]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=108
Labetalol Injection
March 15, 2019
Reason for the Shortage
Akorn did not provide a reason for the shortage.[1]
Alvogen did not provide a reason for the shortage.[2]
Pfizer has labetalol injection on shortage due to manufacturing delays.[3]
Hikma has labetalol injection on shortage due to increase demand.[4]
Estimated Resupply Dates
Akorn has labetalol 5 mg/mL 20 mL vials on allocation. The 40 mL vials are on back order and the
company cannot estimate a release date.[1]
Alvogen has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company cannot
estimate a release date.[2]
Hikma has labetalol 5 mg/mL 20 mL vials on back order and the company estimates a release date of
mid-March 2019. The 40 mL vials are on allocation.[4]
Pfizer has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company estimates a
release date of December 2019 for the 20 mL vials and July 2019 for the 40 mL vials. The 5 mg/mL 4
mL Carpuject syringes are on back order and the company estimates a release date of March
2019.[3]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=286
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Temazepam Capsules
March 15, 2019
Reason for the Shortage
Ascend did not provide a reason for the shortage.
Major has temazepam on shortage due to manufacturing delays.
Mylan has temazepam on shortage due to manufacturing delays.
Sun Pharma has temazepam available.
Teva has temazepam available.
Mallinckrodt has Restoril capsules available.
Estimated Resupply Dates
Ascend has temazepam 15 mg capsules in 100 count on allocation. The 7.5 mg capsules in 100 count
and 30 mg capsules in 500 count are on back order and the company cannot estimate a release date.
Major has temazepam 7.5 mg capsules in 100 count bottles on back order and the company cannot
estimate a release date.
Mylan has temazepam 15 mg capsules in 100 and 500 count, 22.5 mg capsules in 30 count, and 30
mg capsules in 100 and 500 count on back order and the company estimates a release date of August
2019.
Mylan Institutional has temazepam 30 mg capsules in 100 count unit-dose packs on back order and
the company estimates a release date of early-September 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=503
23.4% Sodium Chloride Injection
March 18, 2019
Reason for the Shortage
Fresenius Kabi has 23.4% sodium chloride injection on shortage due to increased demand.
Pfizer has 23.4% sodium chloride injection on shortage due to increased demand.
Estimated Resupply Dates
Fresenius Kabi has 23.4% sodium chloride 200 mL vials on back order and the company estimates a
release date of mid-April 2019. Check wholesalers for inventory.
Pfizer has 23.4% sodium chloride 200 mL vials on back order and the company estimates a release
date of September 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=336
Acetazolamide Injection
March 18, 2019
Reason for the Shortage
Hikma did not provide a reason for the shortage.
Mylan Institutional did not provide a reason for the shortage.
X-Gen has acetazolamide on shortage due to manufacturing delays.
Estimated Resupply Dates
Hikma has acetazolamide 500 mg vials on allocation.
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Mylan Institutional has acetazolamide 500 mg vials on back order and the company cannot estimate
a release date.
X-Gen has acetazolamide 500 mg vials on back order and the company estimates a release date of
late-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=528
Acetylcysteine Oral and Inhalation Solution
March 18, 2019
Reason for the Shortage
American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing
delays. They are not currently marketing the 10 mL and 30 mL vial presentations.
Fresenius Kabi has acetylcysteine oral and inhalation solution available.
Pfizer had acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.
Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.
Arbor has Cetylev effervescent tablets available. These are for oral use only.
Estimated Resupply Dates
American Regent has acetylcysteine solution 100 mg/mL 4 mL vials available in limited supply.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=43
Bacteriostatic 0.9% Sodium Chloride Vials
March 18, 2019
Reason for the Shortage
Fresenius Kabi did not provide a reason for the shortage.
Pfizer has bacteriostatic sodium chloride vials on shortage due to manufacturing delays.
Estimated Resupply Dates
Pfizer has bacteriostatic 0.9% sodium chloride 30 mL vials on back order and the company estimates
a release date of May 2019. The 10 mL and 20 mL vials are available in limited supply.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=441
Bupivacaine Injection
March 18, 2019
Reason for the Shortage
AuroMedics has not provided a reason for the shortage.
Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product.
Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5%
bupivacaine 30 mL glass ampules in December 2017.
Estimated Resupply Dates
AuroMedics has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on intermittent back
order and the company is releasing product as it becomes available. The 0.5% bupivacaine 10 mL and
30 mL preservative-free vials are on intermittent back order and the company is releasing product as
it becomes available. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on
intermittent back order and the company is releasing product as it becomes available.
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Fresenius Kabi has 0.25% Sensorcaine 10 mL preservative-free vials on back order and the company
estimates a release date of late-March 2019. The 0.25% 30 mL preservative-free vials are on back
order and the company estimates a release date of mid- to late-March 2019. The 0.25% 50 mL vials
are on back order and the company estimates a release date of mid- to late-March 2019. The 0.5%
Sensorcaine 10 mL preservative-free vials are on back order and the company estimates release
dates of mid- to late-March 2019. The 0.5% Sensorcaine 30 mL preservative-free vials are on back
order and the company estimates release dates of late-March 2019. The 0.5% Sensorcaine 50 mL
vials are on back order and the company estimates a release date of early-April 2019. The 0.25% and
0.5% Sensorcaine 30 mL preservative-free vials in sterile packs are on back order and the company
cannot estimate release dates.
Pfizer has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on back order and the
company estimates a release date of March 2019. The 0.25% bupivacaine 50 mL vials are on back
order and the company estimates release dates of March 2019. The 0.5% bupivacaine 10 mL and 30
mL preservative-free vials are on back order and the company estimates a release date of March
2019 for the 10 mL vials and May 2019 for the 30 mL vials. The 0.5% bupivacaine 50 mL vials are on
back order and the company estimates a release date of March 2019. The 0.75% bupivacaine 10 mL
and 30 mL preservative-free vials are on back order and the company estimates a release date of
March 2019 for the 10 mL vials and June 2019 for the 30 mL vials.
Pfizer has 0.25% Marcaine 10 mL and 30 mL preservative-free vials on back order and the company
estimates a release date of March 2020 for the 10 mL vials and June 2019 for the 30 mL vials. The
0.25% 50 mL vials are on back order and the company estimates a release date of March 2020. The
0.5% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company
estimates a release date of March 2020. The 0.5% 50 mL vials are on back order and the company
estimates a release date of June 2019. The 0.75% Marcaine 10 mL and 30 mL preservative-free vials
are on back order and the company estimates a release date of March 2020.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=172
Dexamethasone Sodium Phosphate Injection
March 18, 2019
Reason for the Shortage
American Regent is not marketing dexamethasone sodium phosphate injection at this time.
AuroMedics has dexamethasone sodium phosphate on intermittent back order.
Fresenius Kabi has dexamethasone sodium phosphate presentations available.
Mylan Institutional has dexamethasone sodium phosphate available.
Hikma did not provide a reason for the shortage.
Estimated Resupply Dates
AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 mL, 5mL, and 30 mL vials on
intermittent back order and the company is releasing product as it becomes available.
Fresenius Kabi has dexamethasone sodium phosphate 4 mg/mL 1 mL prefilled syringes on back order
and the company estimates a release date of 2nd quarter 2019. The 10 mg/mL 1 mL preservative-
free vials are on back order and the company estimates a release date of mid-April 2019. The 4
mg/mL 1 mL and 5 mL vials are on back order and the company estimates a release date of mid- to
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late-March 2019. The 10 mg/mL 10 mL vials are on back order and the company estimates a release
date of late-April to early-May 2019.
Hikma has dexamethasone sodium phosphate 4 mg/mL 1 mL and 5 mL vials on back order and the
company cannot estimate a release date. The 10 mg/mL 1 mL vials are on allocation.
Mylan Institutional has dexamethasone 40 mg/mL 5 mL and 30 mL vial on back order and the
company estimates a release date of mid- to late-June 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=140
Diphenhydramine Injection
March 18, 2019
Reason for the Shortage
Fresenius Kabi has diphenhydramine injection on shortage due to increased demand.[1]
Hikma did not provide a reason for the shortage.[2]
Mylan did not provide a reason for the shortage.[3]
Pfizer has dipehnhydramine injection on shortage due to manufacturing delays.[4]
Estimated Resupply Dates
Fresenius Kabi has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates
a release date of mid- to late-March 2019. Check wholesalers for inventory.[1]
Mylan Institutional has diphenhydramine 50 mg/mL 10 mL vials on back order and the company
estimates a release date of mid-April 2019.[3]
Pfizer has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release
date of March 2020.[4]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=456
Hydromorphone Hydrochloride Injection
March 18, 2019
Reason for the Shortage
Akorn has hydromorphone injection on shortage due to increased demand.[1]
Fresenius Kabi has Dilaudid syringes on shortage due to increased demand. They are focusing their
product on the 0.5 mg strength. They launched hydromorphone vials in late-June 2018.[2]
Pfizer did not provide a reason for the shortage.[3]
Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons.[4]
Teva did not provide a reason for the shortage.[5]
Hikma did not provide a reason for the shortage.[6]
Estimated Resupply Dates
Fresenius Kabi has Dilaudid 2 mg/mL 1 mL syringes on back order and the company cannot estimate
a release date. The hydromorphone 1 mg/mL 1 mL vials and 4 mg/mL 1 mL vials are on back order
and the company estimates a release date of mid- to late-March 2019. The hydromorphone 10
mg/mL 1 mL vials are on back order and the company cannot estimate a release date. Check
wholesalers for inventory.[2]
Pfizer has 1 mg/mL 1 mL Carpuject syringes available in limited supply. The 10 mg/mL 50 mL vials are
on back order and the company estimates a release date of June 2019. The 10 mg/mL 5 mL vials are
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on back order and the company estimates a release date of April 2019. The 0.5 mg/0.5 mL 0.5 mL
iSecure syringes and 2 mg/mL 1 mL Carpuject syringes are on back order and the company estimates
a release date of June 2019. The 1 mg/mL 1 mL ampules, 2 mg/mL 1 mL ampules, and 4 mg/mL 1 mL
ampules are on back order and the company estimates a release date of June 2019. The 1 mg/mL 1
mL iSecure syringes, 2 mg/mL 1 mL iSecure syringes, and 4 mg/mL 1 mL Carpuject syringes are on
back order and the company estimates a release date of December 2019. The 2 mg/mL 1 mL vials are
available in limited supply.[3]
Teva has 10 mg/mL 1 mL, 5 mL, and 50 mL vials on intermittent back order and the company is
allocating upon release.[5]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=329
Lidocaine Injection
March 18, 2019
Reason for the Shortage
Amphastar had lidocaine 2% emergency syringes on shortage due to increase demand for the
product.
AuroMedics introduced lidocaine injection in February 2014.
Fresenius Kabi had generic lidocaine presentations on shortage due to a supply interruption of raw
ingredients.
Pfizer has lidocaine presentations on shortage due to manufacturing delays.
Estimated Resupply Dates
Amphastar has 2% lidocaine 5 mL syringes on intermittent back order and the company is releasing
product as it becomes available.
AuroMedics has 1% lidocaine 5 mL ampules and 5 mL vials on intermittent back order and the
company is releasing product as it becomes available. AuroMedics has 2% lidocaine 5 mL vials on
intermittent back order and the company is releasing product as it becomes available.
Fresenius Kabi has 1% Xylocaine 20 mL vials on back order and the company estimates a release date
of mid- to late-March 2019. The 1% Xylocaine-MPF 2 mL and 30 mL vials are on back order and the
company estimates a release date of early- to mid-April 2019 for the 2 mL vials and early-April 2019
for the 30 mL vials. The 1% lidocaine 2 mL vials are on back order and the company cannot estimate
a release date. The 1% lidocaine 10 mL vials are on back order and the company estimates a release
date of early-April 2019. The 1% Xylocaine-MPF 30 mL vial sterile packs are on back order and the
company cannot estimate a release date. The 1.5% Xylocaine-MPF 10 mL ampules are on back order
and the company cannot estimate a release date.The 2% Xylocaine 20 mL vials are on back order and
the company estimates a release date of mid- to late-March 2019. Check wholesalers for inventory.
Hikma has 2% lidocaine 5 mL vials on allocation.
Pfizer has 1% lidocaine 5 mL preservative-free ampules on back order and the company estimates a
release date of March 2020. The 1% lidocaine 20 mL vials are on back order and the company
estimates a release date of March 2019. The 1% lidocaine 30 mL preservative-free vials are on back
order and the company estimates a release date of March 2019. The 1% lidocaine 50 mL vials are on
back order and the company estimates a release date of March 2019. The 1% lidocaine 5 mL
Lifeshield syringes are on back order and the company estimates a release date of August 2019. The
1.5% lidocaine 10 mL preservative-free ampules are on back order and the company cannot estimate
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a release date. The 1.5% lidocaine 20 mL preservative-free ampules are on back order and the
company estimates a release date of mid-March 2019. The 2% lidocaine 10 mL ampules are on back
order and the company estimates a release date of June 2019. The 2% lidocaine 5 mL vials are on
back order and the company estimates a release date of December 2019. The 2% lidocaine 20 mL
vials are on back order and the company estimates a release date of June 2019. The 2% lidocaine 50
mL vials are available in limited supply. The 2% lidocaine 5 mL Lifeshield syringes are on back order
and the company estimates a release date of July 2019. The 2% lidocaine 5 mL Ansyr syringes are
available in limited supply. The 4% lidocaine 5 mL ampules are on back order and the company
estimates a release date of April 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=88
Lidocaine with Epinephrine Injection
March 18, 2019
Reason for the Shortage
Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to increased demand
for the product and manufacturing delays.
Pfizer has lidocaine with epinephrine presentations on shortage due to manufacturing delays.
Estimated Resupply Dates
Fresenius Kabi has 0.5% Xylocaine with epinephrine (1:200,000) 50 mL vials on back order and the
company estimates a release date of late-March 2019. The 1% Xylocaine with epinephrine
(1:200,000) 20 mL vials are on back order and the company estimates release dates of mid- to late-
March 2019. The 1% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the
company estimates release dates of mid- to late-March 2019. The 1% Xylocaine-MPF with
epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot
estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials are on
back order and the company estimates a release date of mid-March 2019. The 1.5% Xylocaine-MPF
with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot
estimate a release date. The 2% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back
order and the company estimates a release date of mid- to late-March 2019. The 2% Xylocaine-MPF
with epinephrine (1:200,000) 20 mL vials in sterile packs are on back order and the company cannot
estimate a release date. Check wholesalers for inventory.
Pfizer has 1% lidocaine with epinephrine (1:100,000) 20 mL vials on back order and the company
estimates a release date of March 2019. The 1% lidocaine with epinephrine (1:100,000) 30 mL vials
are on back order and the company estimates a release date of March 2019. The 1% lidocaine with
epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of
March 2019. The 1.5% lidocaine with epinephrine (1:200,000) 30 mL vials are on back order and the
company estimates a release date of June 2019. The 1.5% lidocaine with epinephrine (1:200,000) 5
mL glass ampules are available in limited supply. The 2% lidocaine with epinephrine (1:100,000) 20
mL vials are on back order and the company estimates a release date of March 2019. The 2%
lidocaine with epinephrine (1:100,000) 30 mL and 50 mL vials are on back order and the company
estimates a release date of April 2019 for the 30 mL vials and June 2019 for the 50 mL vials.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=98
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Mepivacaine Injection
March 18, 2019
Reason for the Shortage
Fresenius Kabi did not provide a reason for the shortage.
Pfizer states the reason for the shortage is manufacturing delays.
Estimated Resupply Dates
Fresenius Kabi has 2% Polocaine 50 mL vials on back order and the company estimates a release date
of mid- to late-March 2019. The 2% Polocaine-MPF 20 mL vials are on back order and the company
estimates a release date of late-April 2019. Check wholesalers for inventory.
Pfizer has 2% Carbocaine 20 mL preservative-free vials, 2% Carbocaine 50 mL multiple-dose vials, 1%
Carbocaine 30 mL preservative-free vials, 1% Carbocaine 50 mL multiple-dose vials, and 1.5%
Carbocaine 30 mL preservative-free vials on back order and the company estimates a release date of
March 2020.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=331
Mitoxantrone Hydrochloride Injection
March 18, 2019
Reason for the Shortage
Fresenius Kabi has mitoxantrone available.[1]
Pfizer had mitoxantrone injection on shortage due to manufacturing delays.[2]
Teva has mitoxantrone injection available except for the 10 mL vials which are temporarily
discontinued.[3]
Estimated Resupply Dates
Fresenius Kabi has short-dated mitoxantrone 2 mg/mL 15 mL vials available with an expiration date
of <7 months.[1]
Pfizer has mitoxantrone 2 mg/mL 12.5 mL vials on back order and the company estimates a release
date of July 2019. There are limited supplies of short-dated 12.5 mL vials with an expiration date of
August 2019.[2]
Teva has temporarily discontinued mitoxantrone 10 mL vials and the company cannot estimate a
release date.[3]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=189
Morphine Injection
March 18, 2019
Reason for the Shortage
Fresenius Kabi procured morphine syringes from BD in 2016. They discontinued the 8 mg/mL and 10
mg/mL 1 mL syringes in early-2018.[1-2]
Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites
and cannot estimate if Astramorph will return.[2]
Pfizer has a shortage of several prefilled syringe products, including morphine, starting in late-July
2017 due to issues at a manufacturing facility. To minimize the impact of the shortage, Pfizer is
prioritizing production of certain morphine Carpuject syringes.[3]
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Hikma did not provide a reason for the shortage.[4]
Estimated Resupply Dates
Fresenius Kabi has morphine 2 mg/mL 1 mL syringes on back order and the company estimates a
release date of early-April 2019. The morphine 4 mg/mL 1 mL syringes are on back order and the
company estimates a release date of 2nd quarter 2019. The morphine 5 mg/mL 1 mL syringes are on
back order and the company estimates a release date of 2nd quarter 2019. The 2 mg/mL 1 mL vials
are on back order and the company estimates a release date of mid-April 2019. The 4 mg/mL 1 mL
vials are on back order and the company estimates a release date of mid-April 2019. The 8 mg/mL 1
mL vials are on back order and the company cannot estimate a release date. Check wholesalers for
inventory.[2]
Pfizer has morphine 2 mg/mL 1 mL Carpuject syringes available in limited supply. The 0.5 mg/mL 10
mL preservative-free vials are on back order and the company estimates a release date of April 2019.
The 1 mg/mL 10 mL preservative-free vials are on back order and the company estimates a release
date of March 2019. The 2 mg/mL 1 mL iSecure syringes, 4 mg/mL 1 mL iSecure syringes, 8 mg/mL 1
mL iSecure syringes, and 10 mg/mL 1 mL iSecure syringes are on back order and the company
estimates a release date of December 2019. The 4 mg/mL 1 mL Carpuject syringes are on back order
and the company estimates a release date of April 2019. The 8 mg/mL 1 mL Carpuject syringes and
10 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of
June 2019. The 25 mg/mL 1 mL preservative-free vials are on back order and the company estimates
a release date of June 2019. The 50 mg/mL 20 mL vials are on back order and the company estimates
a release date of May 2019. The 50 mg/mL 50 mL vials are on back order and the company estimates
a release date of June 2019.[3]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=41
Ondansetron Hydrochloride Injection
March 18, 2019
Reason for the Shortage
Apotex has ondansetron injection available.
Athenex had ondansetron injection on shortage due to increased demand.
AuroMedics did not provide a reason for the shortage.
Fresenius Kabi has ondansetron injection available.
Heritage had ondansetron on shortage due to increased demand. Heritage discontinued
ondansetron 2 mg/mL 2 mL vials in 10 count in late-2018.
Hikma did not provide a reason for the shortage.
Mylan Institutional has ondansetron injection available.
Pfizer has ondansetron injection on shortage due to manufacturing delays.
Sagent has ondansetron injection on shortage due to increased demand and manufacturing delays.
Novartis discontinued Zofran 20 mL vials in May 2018.
Estimated Resupply Dates
AuroMedics has ondansetron 2 mg/mL 2 mL vials and 20 mL vials on intermittent back order and the
company is releasing supplies as they become available.
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Fresenius Kabi has ondansetron 2 mg/mL 20 mL vials on back order and the company estimates a
release date of early-April 2019. There are short-dated 20 mL vials available with an expiration date
of < 2 months.
Hikma has ondansetron 2 mg/mL 20 mL vials in 10 count on back order and the company estimates a
release date of April to May 2019.
Pfizer has ondansetron 2 mg/mL 2 mL iSecure syringes on back order and the company estimates a
release date of December 2019. The 2 mg/mL 20 mL vials are on back order and the company
estimates a release date in September 2019.
Sagent has ondansetron 2 mg/mL 2 mL vials and 20 mL vials on back order and the company cannot
estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=405
Potassium Phosphate Injection
March 18, 2019
Reason for the Shortage
American Regent has not had potassium phosphate injection available since 2012. It is unclear if and
when product will return to market.
Fresenius Kabi had potassium phosphate injection on shortage due to increased demand.
Pfizer had potassium phosphate injection on shortage due to manufacturing delays.
Estimated Resupply Dates
Pfizer has potassium phosphate 3 mmol/mL 15 mL vials available in limited supply.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=305
Ropivacaine Injection
March 18, 2019
Reason for the Shortage
Akorn has ropivacaine on shortage due to increased demand.
AuroMedics did not provide a reason for the shortage.
Fresenius Kabi has Naropin on shortage due to increased demand and manufacturing delays.
Pfizer had ropivacaine on shortage due to manufacturing delays.
Estimated Resupply Dates
Akorn has ropivacaine 5 mg/mL 30 mL vials on back order and the company cannot estimate a
release date.
AuroMedics has ropivcaine 7.5 mg/mL 20 mL vials and 5 mg/mL 30 mL vials on intermittent back
order and the company is releasing product as it becomes available.
Fresenius Kabi has Naropin 5 mg/mL 30 mL Steripak ampules on back order and the company
estimates a release date of mid-May 2019. The 5 mg/mL 100 mL bottles are on back order and the
company estimates a release date of late-March 2019. Check wholesalers for inventory.
Pfizer has ropivacaine 2 mg/mL 10 mL and 20 mL vials, 5 mg/mL 30 mL vials and 7.5 mg/mL 20 mL
vials, and 10 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date
of July 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=384
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Levothyroxine Sodium Injection
March 19, 2019
Reason for the Shortage
Athenex started marketing levothyroxine sodium in January 2019
Fresenius Kabi has levothyroxine sodium available.
Par had levothyroxine sodium on shortage due to increased demand.
Piramal Critical Care did not provide a reason for the shortage.
Estimated Resupply Dates
Piramal Critical Care has levothyroxine 100 mcg vials on back order and the company cannot
estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=506
Abciximab Injection
March 20, 2019
Reason for the Shortage
Janssen has Reopro on shortage due to a production interruption at their third party manufacturing
site. The contract manufacturer cannot guarantee supply continuity in 2018 and beyond.
There are no other suppliers of abciximab.
Estimated Resupply Dates
Janssen has Reopro on long-term back order and the company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=413
Ampicillin Sodium and Sulbactam Sodium Injection
March 20, 2019
Reason for the Shortage
Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-
Vantage vials.
Sagent has ampicillin sulbactam vials on back order due to manufacturing delays and increased
demand.
Sandoz cannot provide a reason for the shortage.
WG Critical Care states the shortage is due to increased demand.
Estimated Resupply Dates
AuroMedics has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order
and the company cannot estimate a release date.
Fresenius Kabi has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order
and the company cannot estimate a release date.
Hikma has ampicilin sulbactam 15 gram vials on back order and the company estimates a release
date of mid-April to mid-May 2019. The 1.5 gram and 3 gram vials are on allocation.
Mylan Institutional has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and
the company estimates a release date of mid-April 2019 for the 1.5 and 3 gram vials and mid-May
2019 for the 15 gram vials.
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Pfizer has Unasyn 1.5 gram vials and 3 gram vials on back order and the company estimates a release
date of June 2019 for the 1.5 gram vials and March 2019 for the 3 gram vials. Unasyn 15 gram bulk
vials are on back order and the company estimates a release date of March 2020.
Sandoz has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and
the company cannot estimate a release date.
Sagent has ampicillin sulbactam 1.5 gram vials and 15 gram bulk vials on back order and the
company estimates a release date of March 2019. The 3 gram vials are on back order and the
company estimates a release date of May 2019.
WG Critical Care has ampicillin sulbactam 1.5 gram and 3 gram vials on back order and the company
estimates a release date of late-May 2019. The 15 gram bulk vials are on back order and the
company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=159
Diclofenac Sodium 1% Topical Gel
March 20, 2019
Reason for the Shortage
Amneal did not provide a reason for the shortage.
Cipla USA has diclofenac 1% topical gel available.
Endo did not provide a reason for the shortage.
Par did not provide a reason for the shortage.
Estimated Resupply Dates
Amneal has diclofenac 1% topical gel in 100 gram tubes on back order and the company estimates a
release date in early-April 2019.
Endo has diclofenac 1% topical gel in 20 gram and 100 gram tubes on back order and the company
cannot estimate a release date.
Par has diclofenac 1% topical gel in 100 gram tubes on back order and the company estimates a
release date in late-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=546
Exenatide Extended-Release Suspension for Injection
March 20, 2019
Reason for the Shortage
AstraZeneca has Bydureon BCise on shortage due to increased demand.
AstraZeneca has Bydureon Pen available.
Estimated Resupply Dates
AstraZeneca has Bydureon BCise on intermittent back order and the company is releasing supplies as
they become available. The company expects this to be a short-term issue.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=548
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Heparin Injection
March 20, 2019
Reason for the Shortage
Fresenius Kabi has heparin on shortage due to increased demand.
Hikma did not provide a reason for the shortage.
Mylan has heparin presentations available.
Pfizer did not provide a reason for the shortage.
Sagent has heparin on shortage due to manufacturing issues and increased demand.
Estimated Resupply Dates
Fresenius Kabi has heparin 1,000 unit/mL 2 mL and 10 mL vials on back order and the company
estimates a release date of early-April 2019 for the 2 mL vials and late-March 2019 for the 10 mL
vials. The 5,000 unit/mL 10 mL and 10,000 unit/mL 5 mL vials are on back order and the company
estimates a release date of mid- to late-March 2019 for the 5,000 unit/mL 10 mL vials and mid-May
2019 for the 10,000 unit/mL 5 mL vials. The 10,000 unit/mL 4 mL vials are on back order and the
company cannot estimate a release date.
Hikma has 1,000 unit/mL 30 mL vials and 5,000 unit/mL 10 mL vials on back order and the company
cannot estimate a release date. The 1,000 unit/mL 2 mL vials are on back order and the company
estimates a release date of March to April 2019.
Mylan has 5,000 unit/mL 1 mL vials on back order and the company estimates a release date in mid-
May 2019.
Pfizer has 5,000 unit/mL 1 mL Carpuject syringes on back order and the company estimates a release
date of December 2019. The 1,000 unit/mL 10 mL and 5,000 unit/mL 10 mL vials are on back order
and the company cannot estimate a release date. The 1,000 unit/mL 1 mL glass vials, 5,000 unit/mL 1
mL glass vials, and 10,000 unit/mL 1 mL glass vials are on back order and the company estimates a
release date of June 2019. The 10,000 unit/mL 0.5 mL carpuject syringes are on back order and the
company estimates a release date in April 2019. The 1,000 unit/mL 30 mL glass vials are on back
order and the company estimates a release date in March 2019.
Sagent has 1,000 unit/mL 1 mL vials, 1,000 unit/mL 2 mL vials, 5,000 unit/mL 1 mL vials, and 10,000
unit/mL 4 mL vials on allocation. The 5,000 unit/mL 10 mL vials and 10,000 unit/mL 1 mL vials are on
back order and the company estimates a release date of May 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=353
Hydroxyzine Pamoate Oral Capsules
March 20, 2019
Reason for the Shortage
Amneal did not provide a reason for the shortage.
Mylan did not provide a reason for the shortage.
Pfizer did not provide a reason for the shortage.
Rising discontinued hydroxyzine pamoate capsules.
Sandoz did not provide a reason for the shortage.
Teva did not provide a reason for the shortage.
Estimated Resupply Dates
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Amneal has hydroxyzine pamoate capsules on back order and the company estimates a release date
in early-April 2019.
Mylan has hydroxyzine pamoate 25 mg and 50 mg capsules in 100 count unit dose packages on back
order and the company estimates release dates in early-June 2019 for the 25 mg capsules and early-
May 2019 for the 50 mg capsules.
Pfizer has Vistaril 25 mg and 50 mg capsules in 100 count bottles on back order and the company
estimates a release date in late-March 2019.
Sandoz has hydroxyzine pamoate 50 mg capsules on back order and the company estimates a
release date in late-March 2019.
Teva has hydroxyzine pamoate 25 mg, 50 mg, and 100 mg capsules on back order and the company
estimates a release date in late-June 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=545
Immune Globulin, Subcutaneous (Human)
March 20, 2019
Reason for the Shortage
Baxalta has HyQvia and Cuvitru on shortage due to increased demand.
CSL Behring has Hizentra available.
Estimated Resupply Dates
Baxalta has Cuvitru on allocation and the company is reviewing all orders.
Baxalta has HyQvia on allocation and the company is reviewing all orders.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=515
Iopamidol Injection
March 20, 2019
Reason for the Shortage
Bracco Diagnostics is the sole supplier of iopamidol and did not provide a reason for the shortage.
Estimated Resupply Dates
Bracco Diagnostics has Isovue-300 (iopamidol 61%) in 75 mL, 200 mL, and 500 mL bottles on back
order and the company cannot estimate a release date. Isovue-300 in 50 mL vials are on back order
and the company estimates a release date in early-April 2019. Isovue 370 (iopamidol 76%) in 125 mL
bottles are on back order and the company cannot estimate a release date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=495
Methylene Blue
March 20, 2019
Reason for the Shortage
Akorn has methylene blue on shortage due to manufacturing delays. They are not currently
marketing the 1 mL vials.[1]
Estimated Resupply Dates
Akorn has methylene blue 10 mg/mL 10 mL vials on back order and the company cannot estimate a
release date.[1]
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https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=47
Nitrofurantoin Oral Suspension
March 20, 2019
Reason for the Shortage
Amneal did not provide a reason for the shortage.
Casper Pharma did not provide a reason for the Furadantin shortage.
Lupin is no longer manufacturing this product.
Nostrum has nitrofurantoin oral suspension available.
Teva did not provide a reason for the shortage.
Estimated Resupply Dates
Amneal has nitrofurantoin oral suspension on back order and the company cannot estimate a
release date.
Casper has Furadantin oral suspension available with short expiration dating (May 2019).
Teva has nitrofurantoin oral suspension on back order and the company cannot estimate a release
date.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=433
Nystatin Oral Suspension
March 20, 2019
Reason for the Shortage
Akorn did not provide a reason for the shortage.
Pharmaceutical Associates, Inc. did not provide a reason for the shortage.
Precision Dose has nystatin suspension on allocation due to increased demand.
Vista Pharma did not provide a reason for the shortage.
Wockhardt USA did not provide a reason for the shortage.
Estimated Resupply Dates
Akorn has nystatin 100,000 unit/mL suspension 60 mL and 473 mL bottles on back order and the
company cannot estimate a release date.
Pharmaceutical Associates, Inc. has all nystatin suspension presentations on allocation.
Precision Dose has all nystatin suspension presentations on back order and the company estimates a
release date in early-April 2019.
Vista Pharma has nystatin 100,000 units/mL suspension 60 mL bottles, 480 mL bottles, and 5 mL
unit-dose cups in 100 count on back order and the company cannot estimate release dates.
Wockhardt USA has nystatin 100,000 units/mL suspension 60 mL and 473 mL bottles on back order
and the company estimates a release date of late-March 2019 for the 60 mL bottles and early-April
2019 for the 473 mL bottles.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=500
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Tropicamide 1% Ophthalmic Solution
March 20, 2019
Reason for the Shortage
Akorn did not provide a reason for the shortage.
Alcon has Mydriacyl available.
Bausch Health discontinued tropicamide 1% ophthalmic drops in mid-2018.
Sandoz did not provide a reason for the shortage.
Estimated Resupply Dates
Akorn has tropicamide 1% ophthalmic drops in 15 mL bottles on allocation.
Sandoz has tropicamide 1% ophthalmic drops in 3 mL bottles on back order and the company
estimates a release date in late-March 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=547
Fluconazole Injection
March 21, 2019
Reason for the Shortage
Hikma discontinued fluconazole injection in August 2018.
Pfizer has fluconazole injection on shortage due to manufacturing delays. The 200 mg/100 mL
fluconazole in dextrose bags were discontinued in August 2018.
Renaissance Lakewood Pharmaceuticals bought fluconazole in sodium chloride premixed bags from
Claris Lifescience.
Sagent has fluconazole injection on shortage due to increased demand and manufacturing delays.
Estimated Resupply Dates
Renaissance Lakewood has fluconazole 200 mg/100 mL in 0.9% sodium chloride in 10 count and 400
mg/200 mL in 0.9% sodium chloride in 6 and 10 count on back order and the company cannot
estimate release dates.
Sagent has fluconazole injection 200 mg/100 mL in 0.9% sodium chloride on allocation.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=318
Multiple Vitamins for Infusion
March 21, 2019
Reason for the Shortage
Pfizer states the shortage is due to manufacturing delays.
Baxter has all presentations fully available at this time.
Estimated Resupply Dates
Pfizer has M.V.I. Adult 2 X 5 mL Dual vials, M.V.I. Adult 2 X 50 mL vials, and Pediatric 5 mL vials on
back order and the company estimates a release date of December 2019. There is limited short-
dated product available for the 50 mL adult vials and 5 mL pediatric vials.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=69
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Ranitidine Injection
March 21, 2019
Reason for the Shortage
Mylan has ranitidine injection available.
Teligent has Zantac IV on shortage due to production delays.
Zydus has ranitidine injection available.
Estimated Resupply Dates
Teligent has Zantac 25 mg/mL 2 mL, 6 mL, and 40 mL vials on back order and the company estimates
a release date of 2nd quarter 2019.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=426
Vancomycin Hydrochloride Injection
March 21, 2019
Reason for the Shortage
Alvogen has vancomycin injection available.[1]
Athenex has vancomycin injection available.[2]
AuroMedics has vancomycin injection available.[3]
Pfizer has vancomycin vials on back order due to manufacturing delays.[4]
Fresenius Kabi has vancomycin injection on shortage due to increased demand.[5]
Mylan Institutional has vancomycin injection available.[6]
Baxter has vancomycin injection available.[7]
Samson Medical Technologies has vancomycin injection available.[8]
Sagent has vancomycin injection available.[9]
Xellia Pharmaceuticals has vancomycin injection available.[10]
Estimated Resupply Dates
Pfizer has 500 mg ADD-Vantage vials, 750 mg vials, 750 mg ADD-Vantage vials, 1 gram vials, and 10
gram vials available in limited supply. The 1 gram ADD-Vantage vials are on back order and the
company estimates a release date of April 2019. The 500 mg vials are on back order and the
company estimates a release date in March 2019.[4]
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=25
*Please refer to ASHP website for more information at: https://www.ashp.org/Drug-Shortages/Current-Shortages