Recall Enforment Report D-0593-2024

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Zydus Pharmaceuticals (USA) Inc, originally initiated on 07-02-2024 for the product Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5. The product was recalled due to cross contamination with other products.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0593-202407-02-202407-17-2024Class III8020 vialsVerapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5.Cross contamination with other products.Ongoing
D-0592-202407-02-202407-17-2024Class III170,755 vialsVerapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,Cross contamination with other products.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
70710-1643Verapamil Hydrochloride Verapamil HydrochlorideInjection, SolutionIntravenousZydus Pharmaceuticals Usa Inc.Human Prescription Drug
70710-1644Verapamil Hydrochloride Verapamil HydrochlorideInjection, SolutionIntravenousZydus Pharmaceuticals Usa Inc.Human Prescription Drug