Drug recall D-0316-2021
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.
Reason for recall
Crystallization: customer complaints for crystallization in finished product.
Lots and codes
Lot#: L000126, L000127, Exp 12/31/2021
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Quantity
- 1,638 packs
- Distribution
- USA Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 18, 2021
- Terminated
- November 23, 2022
Related products
- Acyclovir – drug information
- NDC 68382-048 Acyclovir · Acyclovir Sodium 50 mg/mL · Zydus Pharmaceuticals (USA) Inc.
- NDC 68382-049 Acyclovir · Acyclovir Sodium 50 mg/mL · Zydus Pharmaceuticals (USA) Inc.