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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 March 8, 2023 Buspirone Hydrochloride BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Simvastatin Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15,… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Glycopyrrolate Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Aripiprazole Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Rosuvastatin Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Aripiprazole Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Simvastatin Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Dofetilide Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for:… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 PRAVASTATIN SODIUM Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Buspirone Hydrochloride BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for:… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Aripiprazole Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Simvastatin Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15,… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Aripiprazole Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Pirfenidone Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Tadalafil Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10,… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Tadalafil Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10,… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Tadalafil Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10,… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 8, 2023 Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured… Sub-Potent Drug: Out of specification for assay at the 24 month interval. Alvogen, Inc Terminated
Class II March 8, 2023 Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10… CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. Terminated
Class II March 1, 2023 Tacrolimus Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's… Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and… Dr. Reddy's Laboratories, Inc. Ongoing
Class II March 1, 2023 SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun… Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV… B. Braun Medical Inc. Completed
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun… Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV… B. Braun Medical Inc. Completed
Class II March 1, 2023 Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising… Failed Impurities/Degradation Specifications RISING PHARMACEUTICALS Terminated
Class III March 1, 2023 Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid… Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing. Advantice Health, Llc Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II March 1, 2023 Tirosint TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5… Subpotent Drug IBSA PHARMA INC Terminated
Class II February 22, 2023 Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech… CGMP Deviations: initiated due to violations of CGMP manufacturing practices Consolidated Chemical, Inc Ongoing
Class II February 22, 2023 Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis,… CGMP Deviations: initiated due to violations of CGMP manufacturing practices Consolidated Chemical, Inc Ongoing
Class II February 22, 2023 Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL)… Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy. McGuff Compounding Pharmacy Services, Inc. Terminated
Class II February 22, 2023 Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR… Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy. McGuff Compounding Pharmacy Services, Inc. Terminated
Class II February 22, 2023 New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive… cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. HTO Nevada, Inc. Terminated
Class II February 22, 2023 Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure,… cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. HTO Nevada, Inc. Terminated
Class II February 22, 2023 METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only, use with a home pump or no pump, Sentara… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LIP1800ML,… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services,… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a Curlin or… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion Pharmacy… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pharmacy… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c)… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx Only, Sentara… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300,… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only,… Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus. Leadiant Biosciences, Inc. Terminated
Class II February 22, 2023 TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c) 108GM/AA,… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 MYCAMINE 100MG IN NS 100ML, antifungal, Rx Only, use with a homepump, Sentara Home… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Sodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7ML, (e)… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic,… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 PENICILLIN (a) 40MU IN D5W 400ML(CONTINUOUS), (b) 40U IN D5W 400ML(CONTINUOUS), (c) 48MU… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Pharmacy… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 NAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, Rx Only,… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c)… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Sentara Home… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services,… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 MORPHINE Sulfate (a) 1MG/ML IN NS 350ML, (b) 5MG/ML IN NS 200ML, pain, Rx Only, use with… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 KYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion Pharmacy… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Ampicillin/Sulbactam 3GM IN NS 100ML, antibiotic, Rx only, used with a home pump, Sentara… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curlin Pump,… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara Home… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 CEFTRIAXONE (a) 1GM IN NS 50ML, (b)4GM IN NS 200ML, (c) 8GM IN NS 400ML, antibiotic, Rx… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27GM IN NS… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only, used with a… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Vancomycin (a) 1.25GM IN NS 250ML, (b) 1.5GM IN NS 300ML, (c) 1000MG IN NS 200ML (d) 2GM… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services, 535… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 INTRALIPID 18GM, TPN, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 CEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE, (d) 3GM IN… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 DOBUTAMINE, (a) 1080MG IN D5W 270ML, (b) 760MG IN D5W 190ML, ionotrop, used with a home… Lack of sterility assurance Sentara Infusion Services Terminated
Class II February 22, 2023 Bupropion Hydrochloride BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only,… Failed Impurities/Degradation Specifications Amerisource Health Services LLC Terminated
Class II February 22, 2023 Metoprolol succinate Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count… Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which… Amerisource Health Services LLC Terminated
Class II February 15, 2023 Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles. CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. Urban Electric Power Terminated
Class III February 15, 2023 Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL… Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability… Akorn, Inc. Ongoing
Class II February 15, 2023 Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL… CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. Urban Electric Power Terminated
Class II February 15, 2023 Posaconazole Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for:… Failed Impurities/Degradation Specifications: High Out Of Specification degradation results. BIOCON PHARMA INC Terminated
Class II February 8, 2023 Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL… cGMP Deviations Frenda Corporation Terminated
Class II February 8, 2023 Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum,… CGMP deviations DISCOVERY PHARMA LLC Terminated
Class II February 8, 2023 Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda… cGMP Deviations Frenda Corporation Terminated
Class II February 8, 2023 Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048… cGMP Deviations Frenda Corporation Terminated
Class II February 8, 2023 Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946… cGMP Deviations Frenda Corporation Terminated
Class II February 8, 2023 Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5;… cGMP Deviations Frenda Corporation Terminated
Class II February 8, 2023 Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8… cGMP Deviations Frenda Corporation Terminated
Class II February 8, 2023 Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.),… cGMP Deviations Frenda Corporation Terminated
Class I February 8, 2023 Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Care first aid… Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus… GFA Production Xiamen Co. Ltd. Terminated
Class I February 8, 2023 Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After Burn Cream… Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus… GFA Production Xiamen Co. Ltd. Terminated
Class II February 8, 2023 Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count… Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution… SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class I February 8, 2023 Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid… Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus… GFA Production Xiamen Co. Ltd. Terminated
Class I February 8, 2023 Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid… Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus… GFA Production Xiamen Co. Ltd. Terminated
Class I February 8, 2023 Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride… Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus… GFA Production Xiamen Co. Ltd. Terminated
Class I February 8, 2023 Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid… Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus… GFA Production Xiamen Co. Ltd. Terminated
Class I February 8, 2023 Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid… Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus… GFA Production Xiamen Co. Ltd. Terminated
Class I February 8, 2023 Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9… Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus… GFA Production Xiamen Co. Ltd. Terminated
Class I February 8, 2023 CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g… Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus… GFA Production Xiamen Co. Ltd. Terminated
Class I February 8, 2023 Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After Burn Cream… Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus… GFA Production Xiamen Co. Ltd. Terminated
Class II February 1, 2023 KETAMINE 50MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St.,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML (1ML vial) Injectable, Rx… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class I February 1, 2023 Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60… Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back Glaxosmithkline Consumer Healthcare Holdings DBA Haleon Terminated
Class I February 1, 2023 Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever… Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back Glaxosmithkline Consumer Healthcare Holdings DBA Haleon Terminated
Class I February 1, 2023 Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer… Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back Glaxosmithkline Consumer Healthcare Holdings DBA Haleon Terminated
Class II February 1, 2023 Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare,… Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green… Preferred Pharmaceuticals, Inc. Terminated
Class II February 1, 2023 Buprenorphine HCL 0.9 MG/ML (25ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution, Rx Only, Pharmacy Innovations,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 GLYCERIN 72% (W/V) (15ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Estradiol 0.05% OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 MITOMYCIN 0.2MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.2MG/ML (1ML VIAL) OPH… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 METHOTREXATE INTRAVITREAL (1ML VIAL) 4MG/ML (400MCG/0.1ML) INJECTABLE, Rx Only, Pharmacy… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS);… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 HYDROXOCOBALAMIN-PF- 1MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 POLIDOCANOL 50MG/ML (5%) (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innovations, 2936… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Apomorphine HCL 2MG/ML (10ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Cholecalciferol (Vitamin D3) 100,000U/ML Injectable, Rx Only, Pharmacy Innovations, 2936… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St.,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIAL) OPH… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE;… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 VORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Ceftazidime Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable, Rx Only,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St.,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML (5ML VIAL) INJECTABLE, Rx Only, Pharmacy… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Acetylcysteine 10% Ophthalmic Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St.,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 TESTOSTERONE 3% (4GM TUBE) OPHTH OINTME TESTOSTERONE CYP/ANASTROZOLE-GS OIL-… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 PROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1ML VIAL)… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St.,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE;… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE; Rx… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper, Rx Only,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED 14MG/ML… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP/TEST… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, Rx Only,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Edetate Calcium Disodium 400MG/ML (30ML vial) Injectable, Rx Only, Pharmacy Innovations,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St.,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Hydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 METHYLCOBALAMIN 12.5MG/ML (1ML VIAL) INJECTABLE METHYLCOBALAMIN 25MG/ML (1.2ML VIAL)… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St.,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE-… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Innovations,… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 SCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%;… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 LEVEMIR-STS- 100U/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 Methylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylcobalamin… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class II February 1, 2023 FLURBIPROFEN -CORN OIL- 0.04% (3ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy… Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Pharmacy Innovations Terminated
Class III February 1, 2023 FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection… Short Fill: Underfilled units. OurPharma LLC Terminated
Class I February 1, 2023 Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum… Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less… Spectrum Laboratory Products, Inc. Terminated
Class I February 1, 2023 Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed… Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less… Spectrum Laboratory Products, Inc. Terminated
Class II February 1, 2023 Metoprolol succinate Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per… Failed Dissolution Specification Ascend Laboratories, LLC Terminated
Class II February 1, 2023 Metoprolol succinate Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per… Failed Dissolution Specification Ascend Laboratories, LLC Terminated
Class II February 1, 2023 Metoprolol succinate Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per… Failed Dissolution Specification Ascend Laboratories, LLC Terminated
Class II February 1, 2023 Sterile Water Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial,… CGMP Deviations: potential for trace amounts of product carryover. Nephron Sc Inc Terminated
Class III February 1, 2023 Clobetasol Propionate Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin… Subpotent Drug: Low assay result observed during long-term stability testing. Lupin Pharmaceuticals Inc. Terminated
Class II February 1, 2023 S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile… Short Fill Nephron Sc Inc Terminated
Class II February 1, 2023 Allopurinol Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord… Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the… Accord Healthcare, Inc. Terminated
Class II February 1, 2023 Sodium Chloride 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron… CGMP Deviations: potential for trace amounts of product carryover. Nephron Sc Inc Terminated
Class I February 1, 2023 Vancomycin Hydrochloride Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose… Presence of Particulate Matter: Glass particulate matter detected in injectable. Pfizer Inc. Terminated
Class II February 1, 2023 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25),… Short Fill Nephron Sc Inc Terminated
Class II January 25, 2023 rifampin Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed… Failed Impurities/Degradations Specifications Amerisource Health Services LLC Terminated
Class III January 25, 2023 Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules… Failed Impurity/Degradation Specifications Lannett Company Inc. Terminated
Class II January 25, 2023 Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle… CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to… Fisher Scientific Co., LLC Ongoing
Class II January 25, 2023 Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by:… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle,… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn,… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube,… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only,… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by:… CGMP Deviations: Akorn, Inc. Ongoing
Class I January 25, 2023 Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for:… Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial Accord Healthcare, Inc. Terminated
Class II January 25, 2023 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle,… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only,… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle,… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz… CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001… Southwest Iowa Renewable Energy LLC Ongoing
Class II January 25, 2023 Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt.… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by:… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only,… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only,… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl.… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L… CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to… Fisher Scientific Co., LLC Ongoing
Class II January 25, 2023 Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle,… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by:… CGMP Deviations: Akorn, Inc. Ongoing
Class II January 25, 2023 Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube,… CGMP Deviations: Akorn, Inc. Ongoing
Class III January 25, 2023 Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000… Failed Impurity/Degradation Specifications Lannett Company Inc. Terminated
Class III January 25, 2023 SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only,… Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution)… Intersect ENT, Inc. Terminated
Class III January 25, 2023 Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods… Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the… MACLEODS PHARMA USA, INC Terminated
Class II January 25, 2023 SENSORCAINE Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000… Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Fresenius Kabi USA, LLC Terminated
Class II January 25, 2023 SENSORCAINE Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine… Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Fresenius Kabi USA, LLC Terminated
Class II January 25, 2023 Rasagiline Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30;… Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets. Ascend Laboratories, LLC Terminated
Class II January 25, 2023 SENSORCAINE Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000… Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Fresenius Kabi USA, LLC Terminated
Class II January 18, 2023 Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore,… Failed Impurities/Degradation specifications RemedyRepack Inc. Terminated
Class II January 18, 2023 QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE,… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials,… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only,… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only,… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only,… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated