Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIAscorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIMorphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugLongbow First Aid Products ManufactoryClass IIEyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.
CGMP Deviations
- 2018-08-15FDA-DrugLongbow First Aid Products ManufactoryClass IIEmergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY
CGMP Deviations
- 2018-08-15FDA-DrugRight Value Drug Stores, Inc.Class IIITestosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label
- 2018-08-15FDA-DrugAkorn, Inc.Class IILidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
- 2018-08-15FDA-DrugPharMEDium Services, LLCClass II10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
- 2018-08-15FDA-DrugPharMEDium Services, LLCClass II5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
- 2018-08-15FDA-DrugPharMEDium Services, LLCClass II10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
- 2018-08-15FDA-DrugMorton Grove Pharmaceuticals, Inc.Class IIPrednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.
Defective Container: Tamper Evident foil seal not completely intact.
- 2018-08-15FDA-DrugValeant Pharmaceuticals North America LLCClass IIIDiazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215; NDC 68682-650-20.
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
- 2018-08-15FDA-DrugPharmalucence, Inc.Class IIKit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
- 2018-08-15FDA-DrugNuCare Pharmaceuticals IncClass IIValsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-15FDA-DrugNuCare Pharmaceuticals IncClass IIValsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-15FDA-DrugNuCare Pharmaceuticals IncClass IIValsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-15FDA-DrugBaxter Healthcare CorporationClass IIILevofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- 2018-08-15FDA-DrugBaxter Healthcare CorporationClass IIILevofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- 2018-08-15FDA-DrugBaxter Healthcare CorporationClass IIILevofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- 2018-08-08FDA-DrugLupin Pharmaceuticals Inc.Class IIIMoxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
- 2018-08-08FDA-DrugRenaissance Lakewood, LLCClass IIIFluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
- 2018-08-08FDA-DrugRenaissance Lakewood, LLCClass IIIFluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.
Failed Stability Specifications: lot out of specification for elevated water vapor.
- 2018-08-08FDA-DrugRenaissance Lakewood, LLCClass IIIFluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
- 2018-08-08FDA-DrugBryant Ranch Prepack Inc.Class IIValsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-08FDA-DrugBryant Ranch Prepack Inc.Class IIValsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-08FDA-DrugBryant Ranch Prepack Inc.Class IIValsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-08FDA-DrugMAJOR PHARMACEUTICALSClass IIDoxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04
Failed Dissolution Specifications
- 2018-08-08FDA-DrugWest-Ward Columbus IncClass IIDoxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.
Failed Dissolution Specifications:
- 2018-08-08FDA-DrugWest-Ward Columbus IncClass IIDoxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.
Failed Dissolution Specifications:
- 2018-08-08FDA-DrugPFIZERClass IIDaptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
- 2018-08-08FDA-DrugH J Harkins Company Inc dba Pharma PacClass IIValsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
Carcinogen impurity detected in API used to manufacture drug product.
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