Recall Enforment Report D-0316-2021

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Zydus Pharmaceuticals (USA) Inc, originally initiated on 02-18-2021 for the product Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. The product was recalled due to crystallization: customer complaints for crystallization in finished product.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0316-202102-18-202104-07-2021Class I1,638 packsAcyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.Crystallization: customer complaints for crystallization in finished product.Terminated
D-0315-202102-18-202104-07-2021Class I816 packsAcyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.Crystallization: customer complaints for crystallization in finished product.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68382-048Acyclovir AcyclovirInjection, SolutionIntravenousZydus Pharmaceuticals (usa) Inc.Human Prescription Drug
68382-049Acyclovir AcyclovirInjection, SolutionIntravenousZydus Pharmaceuticals (usa) Inc.Human Prescription Drug