Drug 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.
D-0316-2021
Product summary
- Event
- Event 87364
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,638 packs
- Official record key
drug-enforcement:D-0316-2021
Official wording
Reason: Crystallization: customer complaints for crystallization in finished product.
Code information: Lot#: L000126, L000127, Exp 12/31/2021
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Crystallization: customer complaints for crystallization in finished product.