D-0316-2021 Class I Terminated
FDA drug recall D-0316-2021 was initiated by Zydus Pharmaceuticals (USA) Inc on February 18, 2021 and is designated Class I. Reason for recall: Crystallization: customer complaints for crystallization in finished product. The recall status is terminated (terminated November 23, 2022). Affected quantity: 1,638 packs.
Recall Details
- Product Type
- Drugs
- Report Date
- April 7, 2021
- Initiation Date
- February 18, 2021
- Termination Date
- November 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,638 packs
Product Description
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.
Distribution Pattern
USA Nationwide
Code Information
Lot#: L000126, L000127, Exp 12/31/2021