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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 I April 7, 2021 ACYCLOVIR Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous… Crystallization: customer complaints for crystallization in finished product. Zydus Pharmaceuticals (USA) Inc Terminated
Class I April 7, 2021 ACYCLOVIR Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous… Crystallization: customer complaints for crystallization in finished product. Zydus Pharmaceuticals (USA) Inc Terminated
Class II April 7, 2021 ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON… Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into… Ferring Pharmaceuticals Inc Terminated
Class II April 7, 2021 ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON… Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into… Ferring Pharmaceuticals Inc Terminated
Class III April 7, 2021 TREMFYA Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton,… Temperature Abuse Cardinal Health Inc. Terminated
Class I March 31, 2021 Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS… Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. Adams.Secret.co Terminated
Class I March 31, 2021 Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP… Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. Adams.Secret.co Terminated
Class II March 31, 2021 Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by… Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during… Golden State Medical Supply Inc. Terminated
Class II March 31, 2021 Sodium Chloride 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for… Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles… ICU Medical Inc Terminated
Class II March 24, 2021 Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and… cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient… Direct Rx Terminated
Class I March 24, 2021 Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01),… Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets. Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals Ongoing
Class II March 24, 2021 Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed… Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during… Breckenridge Pharmaceutical, Inc Terminated
Class II March 24, 2021 Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured… Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets. Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals Ongoing
Class III March 24, 2021 Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative… Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct… Edge Pharma, LLC Terminated
Class II March 24, 2021 Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per… Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month… Akorn, Inc. Terminated
Class III March 24, 2021 Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe,… Labeling: Incorrect or Missing Lot and/or Exp Date Edge Pharma, LLC Terminated
Class II March 24, 2021 Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25… Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile… Sagent Pharmaceuticals Inc Terminated
Class III March 24, 2021 Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals… Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability… Teva Pharmaceuticals USA Terminated
Class III March 17, 2021 Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of… Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP Ferring Pharmaceuticals Inc Terminated
Class III March 10, 2021 Atorvastatin Calcium Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b)… Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities Dr. Reddy's Laboratories, Inc. Terminated
Class II March 10, 2021 Famotidine Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo… Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine… Aurobindo Pharma USA Inc. Terminated
Class II March 10, 2021 Daytrana Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr)… Defective Delivery System: Out of specification for mechanical peel. Noven Pharmaceuticals Inc Terminated
Class II March 10, 2021 Daytrana Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr)… Defective Delivery System: Out of specification for mechanical peel. Noven Pharmaceuticals Inc Terminated
Class II March 10, 2021 Daytrana Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr),… Defective Delivery System: Out of specification for mechanical peel. Noven Pharmaceuticals Inc Terminated
Class II March 10, 2021 Daytrana Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr),… Defective Delivery System: Out of specification for mechanical peel. Noven Pharmaceuticals Inc Terminated
Class III March 10, 2021 Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only,… Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the… Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II March 10, 2021 metoclopramide Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only,… Chemical contamination; Unknown brown residue adhering to the inside of one vial. Teva Pharmaceuticals USA Terminated
Class II March 10, 2021 Progesterone Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed… Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing. Dr. Reddy's Laboratories, Inc. Terminated
Class III March 10, 2021 CEQUA Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10… Subpotent SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class I March 3, 2021 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world… CareFusion 213, LLC Terminated
Class II March 3, 2021 Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II March 3, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II March 3, 2021 Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01),… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II March 3, 2021 Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II March 3, 2021 Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II March 3, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class I March 3, 2021 ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle,… Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast NDAL Mfg Inc. Ongoing
Class II March 3, 2021 Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01),… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II March 3, 2021 Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II March 3, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II March 3, 2021 Fludeoxyglucose F 18 Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL… Lack of Assurance of Sterility The General Hospital Corporation Terminated
Class II March 3, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II March 3, 2021 Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II March 3, 2021 Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II March 3, 2021 Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx… CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of… Areva Pharmaceuticals Inc Terminated
Class I March 3, 2021 Cisatracurium Besylate Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC… Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as… Meitheal Pharmaceuticals Inc Terminated
Class II March 3, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II March 3, 2021 Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class I March 3, 2021 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage… CareFusion 213, LLC Terminated
Class I March 3, 2021 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage… CareFusion 213, LLC Terminated
Class I March 3, 2021 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world… CareFusion 213, LLC Terminated
Class II March 3, 2021 Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and… Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II March 3, 2021 metoclopramide Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC… Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial… Teva Pharmaceuticals USA Terminated
Class II February 24, 2021 Cephalexin Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only,… CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the… Ascend Laboratories LLC Terminated
Class I February 24, 2021 OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) drum, Made in… Chemical Contamination: Products contain methanol and were below the label claim for ethanol content Liq-E S.A. De C.V. Terminated
Class II February 24, 2021 Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado… Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product. DLC Laboratories, Inc Terminated
Class III February 24, 2021 Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for… Failed Dissolution Specifications Akebia Therapeutics dba Keryx Biopharmaceutials, Inc Terminated
Class II February 24, 2021 Cephalexin Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only,… CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the… Ascend Laboratories LLC Terminated
Class I February 24, 2021 OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L) tank with… Chemical Contamination: Products contain methanol and were below the label claim for ethanol content Liq-E S.A. De C.V. Terminated
Class I February 24, 2021 OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (250 mL)… Chemical Contamination: Products contain methanol and were below the label claim for ethanol content Liq-E S.A. De C.V. Terminated
Class I February 24, 2021 OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L) bottle,… Chemical Contamination: Products contain methanol and were below the label claim for ethanol content Liq-E S.A. De C.V. Terminated
Class II February 24, 2021 Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire… Failed Dissolution Specifications Wilshire Pharmaceuticals Inc Terminated
Class II February 24, 2021 Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire… Failed Dissolution Specifications Wilshire Pharmaceuticals Inc Terminated
Class I February 17, 2021 Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic… Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead… Apotex Corp. Ongoing
Class II February 17, 2021 Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar,… Superpotent Drug. Lidocaine higher concentration than listed Stanley Specialty Pharmacy Compounding and Wellness Center Terminated
Class I February 17, 2021 Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety… Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength)… Apotex Corp. Ongoing
Class III February 17, 2021 Pantoprazole Sodium Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun… Failed Impurity/Degradation Specifications SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class III February 17, 2021 Glycopyrrolate Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx… Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials Accord Healthcare, Inc. Terminated
Class II February 10, 2021 Acetaminophen Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For… Discoloration and failed pH specifications AuroMedics Pharma LLC Terminated
Class III February 10, 2021 Oseltamivir Phosphate Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after… Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month… Lupin Pharmaceuticals Inc. Terminated
Class II February 10, 2021 Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx… CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. Nostrum Laboratories Inc Ongoing
Class II February 10, 2021 Nortriptyline Hydrochloride Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical… CGMP deviations. Taro Pharmaceuticals U.S.A., Inc. Terminated
Class III February 3, 2021 Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant… Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D. Bausch Health Companies, Inc. Terminated
Class III February 3, 2021 Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside… Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D. Bausch Health Companies, Inc. Terminated
Class II February 3, 2021 IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China,… CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be… Shane Erickson Inc Terminated
Class II February 3, 2021 IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottles,… CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be… Shane Erickson Inc Terminated
Class II February 3, 2021 IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Made in China,… CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be… Shane Erickson Inc Terminated
Class I February 3, 2021 KETOROLAC TROMETHAMINE Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials… Presence of Particulate Matter - found in reserve sample vials at the firm. Fresenius Kabi USA, LLC Terminated
Class III February 3, 2021 Testosterone Cypionate Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL… Incorrect Labeling: Incorrect lot number on secondary packaging SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II January 27, 2021 HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate… CGMP deviations: Lack of potency testing. Complete Pharmacy and Medical Solutions, LLC. Terminated
Class II January 27, 2021 HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium… CGMP deviations: Lack of potency testing. Complete Pharmacy and Medical Solutions, LLC. Terminated
Class II January 27, 2021 HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate… CGMP deviations: Lack of potency testing. Complete Pharmacy and Medical Solutions, LLC. Terminated
Class II January 27, 2021 Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10… Failed Dissolution Specifications American Health Packaging Terminated
Class II January 27, 2021 Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml… Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate… Edge Pharma, LLC Terminated
Class II January 27, 2021 HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate… CGMP deviations: Lack of potency testing. Complete Pharmacy and Medical Solutions, LLC. Terminated
Class II January 27, 2021 Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile… Labeling: Missing instructions for use insert Allergan, PLC. Terminated
Class III January 20, 2021 Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US… Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect… US Compounding Inc Terminated
Class II January 20, 2021 Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL)… cGMP deviations: Product made at the same facility where product tested was sub-potent. GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION Ongoing
Class II January 20, 2021 Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA… cGMP deviations: Product made at the same facility where product tested was sub-potent. GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION Ongoing
Class II January 20, 2021 Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged… cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC)… Sunstar Americas, Inc. Ongoing
Class II January 20, 2021 Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml),… Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate… Edge Pharma, LLC Terminated
Class III January 20, 2021 Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only,… Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the… KVK-Tech, Inc. Terminated
Class II January 20, 2021 Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH… Defective container: Customer complaints for oral solution leaking from bottles. Akorn, Inc. Terminated
Class II January 20, 2021 Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups… cGMP deviations: The firm was notified of the manufacturer's expanded recall. Precision Dose Inc. Terminated
Class III January 20, 2021 Oxycodone Hydrochloride Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus… Presence of Foreign Substance: Particulate matter was found in multiple lots of product. Genus Lifesciences Inc. Terminated
Class II January 20, 2021 Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx… CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Nostrum Laboratories Inc Ongoing
Class II January 13, 2021 ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe,… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc.,… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only,… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class III January 13, 2021 Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only,… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe,… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA… Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit SCA Pharmaceuticals Terminated
Class II January 13, 2021 Cephalexin Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed)… Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in… Ascend Laboratories LLC Terminated
Class II January 13, 2021 Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx… Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification.… Merck Sharp & Dohme Terminated
Class II January 6, 2021 Esomeprazole magnesium Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose… Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline CIPLA Terminated
Class II January 6, 2021 Cephalexin Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when… Failed Impurity/Degradation Specifications Ascend Laboratories LLC Terminated
Class II January 6, 2021 Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial,… Lack of assurance of sterility: 13 vials were discovered to have faulty crimps. Imprimis NJOF, LLC Terminated
Class III January 6, 2021 Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office… Labelling: Missing label. US Compounding Inc Terminated
Class II January 6, 2021 Cephalexin Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when… Failed Impurity/Degradation Specifications Ascend Laboratories LLC Terminated
Class II January 6, 2021 Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose… Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline CIPLA Terminated
Class I January 6, 2021 Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO… Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. Wishgarden Herbs, Incorporated Terminated
Class II January 6, 2021 Esomeprazole magnesium Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose… Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline CIPLA Terminated
Class I January 6, 2021 Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC… Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. Wishgarden Herbs, Incorporated Terminated
Class I January 6, 2021 Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301.… Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. Wishgarden Herbs, Incorporated Terminated
Class II January 6, 2021 KETOROLAC TROMETHAMINE Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL… Presence of Particulate Matter - found in reserve sample vials at the firm. Fresenius Kabi USA, LLC Terminated
Class III January 6, 2021 Tacrolimus NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by:… Failed Moisture Limits Strides Pharma Inc. Terminated
Class II December 30, 2020 Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container,… Subpotent drug. SCA Pharmaceuticals, Inc. Terminated
Class II December 30, 2020 Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz… Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone,… Morton Grove Pharmaceuticals, Inc. Terminated
Class II December 30, 2020 Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for… CGMP Deviations Akebia Therapeutics dba Keryx Biopharmaceutials, Inc Terminated
Class II December 30, 2020 SENSORCAINE Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL… Subpotent Drug: Low out-of-specification assay results for the epinephrine component. Fresenius Kabi USA, LLC Terminated
Class II December 23, 2020 Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g),… Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II December 23, 2020 THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine,… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine,… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE… Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party… AVKARE Inc. Terminated
Class II December 23, 2020 CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L),… Subpotent drug Simex Logistics SA de CV Terminated
Class II December 23, 2020 Lavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue… Subpotent drug Simex Logistics SA de CV Terminated
Class II December 23, 2020 IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine,… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis,… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class I December 23, 2020 TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for:… Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party… AVKARE Inc. Terminated
Class II December 23, 2020 CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine,… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine,… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 UVT World Gel Hand Sanitizer 70% Alcohol Content, 33.9 FL OZ (1LT), Distributed By UVT… Subpotent drug Simex Logistics SA de CV Terminated
Class III December 23, 2020 Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821… Subpotency: Out-of-specification stability test result for low potency was obtained. SCA Pharmaceuticals Terminated
Class II December 23, 2020 AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis,… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine,… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 LANSOPRAZOLE Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10… Failed Dissolution Specifications Zydus Pharmaceuticals (USA) Inc Terminated
Class II December 23, 2020 Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed… Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II December 23, 2020 Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg… Cross contamination: the excipient was found to be contaminated with theophylline. BASF Corporation Completed
Class II December 23, 2020 Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g),… Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II December 23, 2020 Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine,… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 Sodium Chloride Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only,… Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml… Hikma Pharmaceuticals USA Inc. Terminated
Class II December 23, 2020 Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g),… Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II December 23, 2020 Health & Hand Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By… Subpotent drug Simex Logistics SA de CV Terminated
Class II December 23, 2020 GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 +Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol… Subpotent drug Simex Logistics SA de CV Terminated
Class II December 23, 2020 DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz.… Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II December 23, 2020 LANSOPRAZOLE Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit… Failed Dissolution Specifications Zydus Pharmaceuticals (USA) Inc Terminated
Class II December 23, 2020 LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine,… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Advanced Nutriceuticals, LLC Ongoing
Class II December 23, 2020 Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count… Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution… Biogen MA Inc. Terminated
Class II December 23, 2020 Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5… Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II December 23, 2020 TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5… Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II December 23, 2020 H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2… Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II December 23, 2020 Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15… Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II December 23, 2020 CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ… Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II December 23, 2020 Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only… cGMP deviations: Vials may not be sealed correctly affecting sterility. CIPLA Terminated
Class II December 16, 2020 Imatinib Mesylate Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa… CGMP Deviations Shilpa Medicare Limited Terminated
Class II December 16, 2020 V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053… Lack of CGMPs: Asiaticon, SA de CV Terminated
Class II December 16, 2020 Imatinib Mesylate Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa… CGMP Deviations Shilpa Medicare Limited Terminated
Class II December 16, 2020 Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400… Lack of CGMPs: Asiaticon, SA de CV Terminated
Class II December 16, 2020 Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx… CGMP Deviations Shilpa Medicare Limited Terminated
Class III December 16, 2020 Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in… Labeling: Label mix-up Novocol Pharmaceutical of Canada, Inc. Terminated
Class II December 16, 2020 Azacitidine Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx… CGMP Deviations Shilpa Medicare Limited Terminated
Class II December 16, 2020 Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8… CGMP Deviations Shilpa Medicare Limited Terminated
Class I December 16, 2020 Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50… Cross Contamination with other products: trace amounts of lidocaine Fresenius Kabi USA, LLC Terminated
Class II December 16, 2020 Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted… CGMP Deviations Shilpa Medicare Limited Terminated
Class III December 9, 2020 Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed… Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed… InvaTech Pharma Solutions, LLC Terminated
Class II December 9, 2020 Tizanidine Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem… Failed Dissolution Specifications; Out of Specification (low) results were obtained. Ascend Laboratories LLC Terminated
Class I December 9, 2020 Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does… Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was… Lohxa LLC Terminated
Class II December 9, 2020 CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by… Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment. US Pharmaceuticals Inc. Terminated
Class II December 9, 2020 ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured… FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf… Golden State Medical Supply Inc. Terminated
Class III December 9, 2020 Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma.… Superpotent and Subpotent; low and high assay results Teligent Pharma, Inc. Terminated
Class II December 9, 2020 Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured… Failed Dissolution Specifications: Out of specification for dissolution. The Harvard Drug Group Terminated
Class I December 9, 2020 REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g),… Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria… MPM Medical LLC Terminated
Class I December 9, 2020 Anagrelide Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent… Failed Dissolution Specifications Torrent Pharma Inc Terminated
Class II December 2, 2020 Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced… Marketed without an Approved NDA/ANDA: Product marketed with drug claims. Fusion Health and Vitality LLC Terminated
Class II December 2, 2020 SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL)… CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be… AA PRODUCTS INC Completed
Class III December 2, 2020 Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent… Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results. Teligent Pharma, Inc. Terminated
Class I December 2, 2020 Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged… Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata. Sunstar Americas, Inc. Completed
Class II December 2, 2020 Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured… Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam… EYWA PHARMA INC Terminated
Class III December 2, 2020 Doxorubicin Hydrochloride DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL… Cross Contamination with Other Products: trace amounts of octreotide found during testing Fresenius Kabi USA, LLC Terminated
Class II December 2, 2020 clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured… Failed Tablet/Capsule Specification Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class III December 2, 2020 Felodipine Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by:… Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine… Heritage Pharmaceuticals Inc Terminated
Class II November 25, 2020 Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 (Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%,… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8… CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content… Albek De Mexico S.A. De C.V. Ongoing
Class II November 25, 2020 DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237… CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content… Albek De Mexico S.A. De C.V. Ongoing
Class II November 25, 2020 Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist.… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237… CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content… Albek De Mexico S.A. De C.V. Ongoing
Class II November 25, 2020 NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl… CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content… Albek De Mexico S.A. De C.V. Ongoing
Class II November 25, 2020 DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Dermatologic… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 (Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by:… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 Sodium Chloride Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative… Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL… Hikma Pharmaceuticals USA Inc. Terminated
Class II November 25, 2020 NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle,… CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content… Albek De Mexico S.A. De C.V. Ongoing
Class II November 25, 2020 DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 (Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II November 25, 2020 Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake… Preferred Pharmaceuticals, Inc. Terminated
Class II November 25, 2020 Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC… Failed Dissolution Specifications: Out of specification for dissolution. Apotex Corp. Terminated
Class II November 25, 2020 Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx… Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg… Ascent Pharmaceuticals, Inc. Terminated
Class III November 25, 2020 Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc.… Labeling: Product Contains Undeclared API; Incorrect formulation Grato Holdings, Inc. Terminated
Class III November 25, 2020 testosterone Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC… Superpotent Drug: High out-of-specification assay results were obtained during stability testing. Teva Pharmaceuticals USA Terminated
Class II November 18, 2020 Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx… Failed Dissolution Specifications AVKARE Inc. Terminated
Class II November 18, 2020 Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x… Presence of particulate matter in solution - black and transparent particles Baxter Healthcare Corporation Terminated
Class II November 18, 2020 White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold by: H & H… CGMP Deviations H & H Remedies, LLC Terminated
Class II November 18, 2020 Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold… CGMP Deviations H & H Remedies, LLC Terminated
Class II November 18, 2020 Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and… CGMP Deviations H & H Remedies, LLC Terminated
Class II November 18, 2020 Mesalamine Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only,… Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. Teva Pharmaceuticals USA Terminated
Class II November 11, 2020 Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only,… CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per… Denton Pharma, Inc. Ongoing
Class III November 11, 2020 Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm… Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity. Teligent Pharma, Inc. Terminated
Class II November 11, 2020 LANSOPRAZOLE Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10… Failed Dissolution Specification Zydus Pharmaceuticals (USA) Inc Terminated
Class II November 11, 2020 Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0 Discoloration. Medichem S.A. Terminated
Class II November 11, 2020 LANSOPRAZOLE Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10… Failed Dissolution Specification Zydus Pharmaceuticals (USA) Inc Terminated