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Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II June 1, 2022 Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamine HCL 1.62… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Vitamin D3 (50,000 IU/mL)Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Cyanocobalamin 2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Calcium Chloride 10% (100 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals,… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dose vial NDC,… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Olympia… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL,… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Lipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL,… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Dexpanthenol 250 mg/mL Multi-Dose 30 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2.5 mg/mL… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuticals, 6700… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vial, Rx… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b)… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympia… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals,… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 losartan potassium and hydrochlorothiazide Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Direct Rx Terminated
Class II June 1, 2022 losartan potassium and hydrochlorothiazide Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Direct Rx Terminated
Class II June 1, 2022 Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By:… CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. Direct Rx Terminated
Class II June 1, 2022 Daytrana Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr)… Defective Delivery System: customer complaints exceeded respective action limits. Noven Pharmaceuticals Inc Ongoing
Class II June 1, 2022 losartan potassium and hydrochlorothiazide Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By:… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Direct Rx Terminated
Class III June 1, 2022 Tivicay Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV… Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product… GlaxoSmithKline LLC Terminated
Class III May 25, 2022 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10),… Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the… American Health Packaging Terminated
Class III May 25, 2022 Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally… Subpotent drug: Low OOS for menthol content at the three month room temperature. Bestco LLC Terminated
Class II May 25, 2022 Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only,… TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to… Cardinal Health Inc. Completed
Class II May 25, 2022 MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10… CGMP Deviations: Failure to properly investigate failed microbial testing. Plastikon Healthcare LLC Completed
Class III May 25, 2022 Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for:… Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content Monarch PCM, LLC Terminated
Class I May 25, 2022 Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup,… Microbial Contamination of Non-Sterile Products Plastikon Healthcare LLC Completed
Class I May 25, 2022 MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10… Microbial Contamination of Non-Sterile Products Plastikon Healthcare LLC Completed
Class II May 25, 2022 Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10… CGMP Deviations: Failure to properly investigate failed microbial testing. Plastikon Healthcare LLC Completed
Class II May 25, 2022 Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup,… CGMP Deviations: Failure to properly investigate failed microbial testing. Plastikon Healthcare LLC Completed
Class II May 25, 2022 Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed… CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Pfizer Inc. Terminated
Class II May 25, 2022 Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed… CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Pfizer Inc. Terminated
Class II May 25, 2022 Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed… CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Pfizer Inc. Terminated
Class II May 25, 2022 Trulicity Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx… TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions Cardinal Health Inc. Completed
Class III May 25, 2022 Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc.… Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit… Apotex Corp. Terminated
Class II May 25, 2022 GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP… Failed Stability Specification Lupin Pharmaceuticals Inc. Terminated
Class I May 25, 2022 Humalog Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens… TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to… Cardinal Health Inc. Completed
Class II May 18, 2022 MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4… Defective container: loose crimp defect, potential loss of container integrity. Amgen, Inc. Terminated
Class II May 18, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister… Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class II May 18, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister… Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class I May 18, 2022 SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC… Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli. Fagron, Inc Completed
Class III May 18, 2022 Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription… Subpotent Drug Fagron, Inc Terminated
Class III May 18, 2022 Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription… Subpotent Drug Fagron, Inc Terminated
Class III May 18, 2022 Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription… Subpotent Drug Fagron, Inc Terminated
Class II May 18, 2022 Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alcohol, OTC,… CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits. Lula Holdings L.L.C. Terminated
Class III May 18, 2022 Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription… Subpotent Drug Fagron, Inc Terminated
Class III May 18, 2022 Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription… Subpotent Drug Fagron, Inc Terminated
Class III May 18, 2022 bupropion hydrochloride buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx… Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle… SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class III May 18, 2022 bupropion hydrochloride buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count… Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle… SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II May 18, 2022 Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only,… Failed Dissolution Specifications: low out of specification results for dissolution. Viatris Inc Terminated
Class II May 11, 2022 Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals… CGMP Deviations SCA Pharmaceuticals Terminated
Class II May 11, 2022 Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by:… CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is… McKesson Corporation dba McKesson Drug Company Ongoing
Class II May 11, 2022 Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as… CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is… McKesson Corporation dba McKesson Drug Company Ongoing
Class II May 11, 2022 Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA… CGMP Deviations SCA Pharmaceuticals Terminated
Class II May 11, 2022 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only,… CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is… McKesson Corporation dba McKesson Drug Company Ongoing
Class II May 11, 2022 Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent… CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is… McKesson Corporation dba McKesson Drug Company Ongoing
Class II May 11, 2022 Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals… CGMP Deviations SCA Pharmaceuticals Terminated
Class II May 11, 2022 Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by:… CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is… McKesson Corporation dba McKesson Drug Company Ongoing
Class III May 11, 2022 Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx… Failed viscosity specification - product was below specificcation Akorn, Inc. Terminated
Class I May 11, 2022 Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands… Chemical Contamination; FDA analysis found product to contain methanol Best Brands Consumer Products, Inc. Terminated
Class II May 11, 2022 Alprazolam alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by:… Failed Dissolution Specifications: low out-of-specification dissolution test results observed. Viatris Inc Terminated
Class II May 11, 2022 Losartan Potassium Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b)… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Macleods Pharma Usa Inc Terminated
Class I May 11, 2022 The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands… Chemical Contamination; FDA analysis found product to contain benzene Best Brands Consumer Products, Inc. Terminated
Class II May 11, 2022 Losartan Potassium Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b)… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Macleods Pharma Usa Inc Terminated
Class II May 11, 2022 Pantoprazole Sodium Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle,… CGMP deviations: tablets cracking Torrent Pharma Inc Terminated
Class II May 11, 2022 Lansoprazole Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets… Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II May 11, 2022 Losartan Potassium Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b)… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Macleods Pharma Usa Inc Terminated
Class II May 11, 2022 Losartan Potassium Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b)… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Lupin Pharmaceuticals Inc. Terminated
Class II May 11, 2022 Losartan Potassium Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b)… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Lupin Pharmaceuticals Inc. Terminated
Class II May 11, 2022 Losartan Potassium Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b)… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Lupin Pharmaceuticals Inc. Terminated
Class II May 11, 2022 Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Lupin Pharmaceuticals Inc. Terminated
Class II May 11, 2022 losartan potassium and hydrochlorothiazide Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Macleods Pharma Usa Inc Terminated
Class II May 11, 2022 Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Lupin Pharmaceuticals Inc. Terminated
Class II May 11, 2022 losartan potassium and hydrochlorothiazide Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Macleods Pharma Usa Inc Terminated
Class II May 11, 2022 Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Lupin Pharmaceuticals Inc. Terminated
Class II May 11, 2022 losartan potassium and hydrochlorothiazide Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Macleods Pharma Usa Inc Terminated
Class I May 4, 2022 Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chlorohydrate… Chemical contamination: presence of benzene Unilever United States Inc. Ongoing
Class II May 4, 2022 Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc.,… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. Preferred Pharmaceuticals, Inc. Terminated
Class III May 4, 2022 Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use… Subpotent Drug: Out of specification for assay. American Health Packaging Terminated
Class II May 4, 2022 Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene Unilever United States Inc. Ongoing
Class III May 4, 2022 Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed… Incorrect/Undeclared Excipient: Product contains alcohol AptaPharma Inc. Terminated
Class II May 4, 2022 Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC… cGMP Deviations Teva Pharmaceuticals USA Inc Terminated
Class II May 4, 2022 RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 10 mL… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only,… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 mL… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10 mL… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, Rx Only,… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atropine 0.2… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Multi-Dose vial,… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atropine 0.2… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in a)… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dose 10 ml… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose 10 ml vial,… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . Atropine 0.2… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/mL, Multi-Dose 10 mL vial,… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose… Failed Reconstitution time Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Multi-Dose… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 QM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL . Atropine 0.2… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 T-106, Papaverine 30 mg/mL . Phentolamine 1 mg/mL . Alprostadil 25 mcg/mL, Packaged as a)… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in a) 10 mL Multi-Dose vial,… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg/mL.… CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions… Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II May 4, 2022 TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand… CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. Torco Race Fuels Terminated
Class I May 4, 2022 Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a… Labeling: Missing label on the vial Mylan Pharmaceuticals Inc Terminated
Class II May 4, 2022 Zonisamide Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by:… cGMP deviations Glenmark Pharmaceuticals Inc., USA Completed
Class II May 4, 2022 Zonisamide Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b)… cGMP deviations Glenmark Pharmaceuticals Inc., USA Completed
Class II May 4, 2022 Zonisamide Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by:… cGMP deviations Glenmark Pharmaceuticals Inc., USA Completed
Class II May 4, 2022 Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b)… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. RemedyRepack Inc. Terminated
Class II April 27, 2022 BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave… Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the… North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding Terminated
Class II April 27, 2022 PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio… Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the… North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding Terminated
Class II April 27, 2022 Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx… Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the… North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding Terminated
Class II April 27, 2022 Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N… Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the… North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding Terminated
Class II April 27, 2022 Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville… Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the… North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding Terminated
Class II April 27, 2022 LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave… Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the… North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding Terminated
Class II April 27, 2022 ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio… Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the… North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding Terminated
Class II April 27, 2022 Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx… CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is… Preferred Pharmaceuticals, Inc. Terminated
Class II April 27, 2022 artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236… CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot VIRGIN SCENT INC Terminated
Class II April 27, 2022 artnaturals Hand Sanitizer CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot VIRGIN SCENT INC Terminated
Class I April 27, 2022 Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured… Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient… Pink Toyz Terminated
Class I April 27, 2022 artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236… Chemical Contamination: presence of benzene, acetaldehyde, and acetal. VIRGIN SCENT INC Terminated
Class II April 27, 2022 Rifampin Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for:… Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during… Mylan Pharmaceuticals Inc Terminated
Class II April 20, 2022 Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release… Out of specification results observed in dissolution during long term stability testing. Preferred Pharmaceuticals, Inc. Terminated
Class II April 20, 2022 Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg:… CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is… Preferred Pharmaceuticals, Inc. Terminated
Class II April 20, 2022 Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred… CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is… Preferred Pharmaceuticals, Inc. Terminated
Class I April 20, 2022 IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single… Presence of Particulate Matter: Product was found to contain silica and iron oxide Teva Pharmaceuticals USA Inc Terminated
Class III April 20, 2022 Cyanocobalamin Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx… Subpotent Drug: Out of Specification results for Assay Aurobindo Pharma USA Inc. Terminated
Class II April 13, 2022 quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only,… CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Pfizer Inc. Terminated
Class III April 13, 2022 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx… Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg… The Ritedose Corporation Terminated
Class I April 13, 2022 SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled Single-Dose… Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine. Adamis Pharmaceuticals Corporation Terminated
Class I April 13, 2022 SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose… Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine. Adamis Pharmaceuticals Corporation Terminated
Class II April 13, 2022 Orphenadrine Citrate Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets,… CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. Sandoz, Inc Terminated
Class II April 13, 2022 quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed… CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Pfizer Inc. Terminated
Class II April 13, 2022 Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups… Labeling: Label Mix-Up DASH Pharmaceuticals LLC Terminated
Class II April 13, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx… CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Pfizer Inc. Terminated
Class II April 13, 2022 TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use… Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the… Vitae Enim Vitae Scientific, Inc. Terminated
Class II April 13, 2022 quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only,… CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Pfizer Inc. Terminated
Class II April 13, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles,… CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Pfizer Inc. Terminated
Class II April 13, 2022 The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (500 mL,… Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage… Revive Personal Products Company Terminated
Class II April 13, 2022 PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL… Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the… Vitae Enim Vitae Scientific, Inc. Terminated
Class II April 13, 2022 PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box… Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the… Vitae Enim Vitae Scientific, Inc. Terminated
Class II April 13, 2022 PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC… Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the… Vitae Enim Vitae Scientific, Inc. Terminated
Class II April 13, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles,… CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Pfizer Inc. Terminated
Class II April 13, 2022 Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for:… Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay… Mylan Pharmaceuticals Inc Terminated
Class II April 13, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx… CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Pfizer Inc. Terminated
Class II April 13, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets… CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Pfizer Inc. Terminated
Class III April 13, 2022 Risedronate Sodium Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for:… FAILED CONTENT UNIFORMITY SPECIFICATIONS Macleods Pharma Usa Inc Terminated
Class III April 13, 2022 Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant… Subpotent Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class III April 13, 2022 CEQUA Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use… Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence… SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class III April 13, 2022 NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit… Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies. Advanced Accelerator Applications USA, Inc. Terminated
Class II April 13, 2022 JANUMET Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged… Presence of foreign substance: Presence of stainless steel particulates in tablets. MERCK SHARP & DOHME CORP Terminated
Class III April 6, 2022 Atorvastatin Calcium Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's… Failed Impurities/Degradation Specifications: Out of Specification results for related substance. Dr. Reddy's Laboratories, Inc. Terminated
Class II April 6, 2022 TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial,… Lack of sterility assurance. Drug Depot, Inc., dba APS Pharmacy Terminated
Class II April 6, 2022 (CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula… Lack of sterility assurance. Drug Depot, Inc., dba APS Pharmacy Terminated
Class II April 6, 2022 TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML… Lack of sterility assurance. Drug Depot, Inc., dba APS Pharmacy Terminated
Class II April 6, 2022 TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in… Lack of sterility assurance. Drug Depot, Inc., dba APS Pharmacy Terminated
Class II April 6, 2022 TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi… Lack of sterility assurance. Drug Depot, Inc., dba APS Pharmacy Terminated
Class II April 6, 2022 TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi… Lack of sterility assurance. Drug Depot, Inc., dba APS Pharmacy Terminated
Class II April 6, 2022 Lansoprazole Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC… Failed Dissolution Specifications; during long term stability testing. Dr. Reddy's Laboratories, Inc. Terminated
Class II April 6, 2022 TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML… Lack of sterility assurance. Drug Depot, Inc., dba APS Pharmacy Terminated
Class II April 6, 2022 GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula… Lack of sterility assurance. Drug Depot, Inc., dba APS Pharmacy Terminated
Class II April 6, 2022 Lansoprazole Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured… Failed Dissolution Specifications; during long term stability testing. Dr. Reddy's Laboratories, Inc. Terminated
Class I April 6, 2022 Meclizine Hydrochloride Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count… Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets… Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II April 6, 2022 GLYCOPYRROLATE Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo… Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment… Aurolife Pharma, LLC Terminated
Class III April 6, 2022 Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only,… Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II March 30, 2022 Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by:… Defective Container: Leaking containers. Direct Rx Terminated
Class III March 30, 2022 Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium… Sub Potent Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II March 30, 2022 Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel… Defective container Athenex Pharma Solutions, LLC Terminated
Class I March 30, 2022 REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth… Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus. Blaine Labs Inc Terminated
Class III March 30, 2022 SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL… Sub Potent Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II March 30, 2022 Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only,… Defective container Athenex Pharma Solutions, LLC Terminated
Class II March 30, 2022 Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx… Defective container Athenex Pharma Solutions, LLC Terminated
Class II March 30, 2022 Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel… Defective container Athenex Pharma Solutions, LLC Terminated
Class II March 30, 2022 NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose… Product found to be Sub Potent or Exceeded reconstitution time Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II March 30, 2022 Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL… Defective container Athenex Pharma Solutions, LLC Terminated
Class II March 30, 2022 Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16… Defective container Athenex Pharma Solutions, LLC Terminated
Class II March 30, 2022 HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters… CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same… Tennessee Technical Coatings, Corp. Terminated
Class II March 30, 2022 Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg,… Super Potent and Failed Reconstitution Time Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class III March 30, 2022 Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01… Sub Potent Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class I March 30, 2022 HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters… Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain… Tennessee Technical Coatings, Corp. Terminated
Class II March 30, 2022 ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution… CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits. Rock Town Distillery, Inc. Terminated
Class III March 30, 2022 T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL… Super Potent Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II March 30, 2022 Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL… Defective container Athenex Pharma Solutions, LLC Terminated
Class II March 30, 2022 Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each… Sub Potent Olympia Compounding Pharmacy dba Olympia Pharmacy Terminated
Class II March 30, 2022 Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b)… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by:… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20;… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for:… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15;… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N.… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by:… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only,… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes,… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only,… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for:… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by:… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma,… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b)… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt.… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for:… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b)… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma,… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b)… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15;… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for:… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for:… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class II March 30, 2022 Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured… cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study… Teligent Pharma, Inc. Terminated
Class I March 30, 2022 sodium acetate Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20… Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace… Fresenius Kabi USA, LLC Terminated
Class II March 30, 2022 TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile… Lack of Assurance of Sterility Akorn, Inc. Terminated