Drug and pharmaceutical recalls

17623 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2023-05-31FDA-DrugAurobindo Pharma USA Inc.Class II
Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
2023-05-31FDA-DrugSagent Pharmaceuticals IncClass II
Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99
Lack of Assurance of Sterility
2023-05-31FDA-DrugSagent Pharmaceuticals IncClass II
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Lack of Assurance of Sterility
2023-05-31FDA-DrugSagent Pharmaceuticals IncClass II
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
Lack of Assurance of Sterility
2023-05-31FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass II
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Failed Dissolution Specifications; during stability testing
2023-05-31FDA-DrugAlpha AromaticsClass II
FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
2023-05-31FDA-DrugAmerisource Health Services LLCClass II
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
CGMP Deviations: recalling drug products following an FDA inspection.
2023-05-31FDA-DrugAmerisource Health Services LLCClass II
Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories
CGMP Deviations: recalling drug products following an FDA inspection.
2023-05-31FDA-DrugAmerisource Health Services LLCClass II
Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
CGMP Deviations: recalling drug products following an FDA inspection.
2023-05-31FDA-DrugAmneal Pharmaceuticals of New York, LLCClass III
Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01.
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8077-1, code 7128580771.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8029-1, code 7128580291.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9002-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9001-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9000-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8100-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8097-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8096-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8095-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
EPINEPHrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8093-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8069-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
heparin added to 0.9% sodium chloride, 2,500 units/250 mL* (10 units/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8000-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7090-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7089-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
2023-05-31FDA-DrugCentral Admixture Pharmacy Services, Inc.Class II
vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7060-1.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

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