Drug product
Acyclovir 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.
D-0315-2021
Product summary
- Event
- Event 87364
- Status
- Terminated
- Classification
- Class I
- Quantity
- 816 packs
- Official record key
drug-enforcement:D-0315-2021
Official wording
Reason: Crystallization: customer complaints for crystallization in finished product.
Code information: Lot#: L000155, Exp 12/2021; L000156, Exp 1/2022
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Crystallization: customer complaints for crystallization in finished product.