FDA Recall D-0315-2021
Zydus Pharmaceuticals (USA) Inc · Pennington, NJ
Class I — life-threatening Terminated 643 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Reason for recall
Crystallization: customer complaints for crystallization in finished product.
Recall record
- Recall number
D-0315-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA Nationwide
- Recall initiated
- 2021-02-18
- Classified by FDA Center
- 2021-03-30
- FDA published
- 2021-04-07
- Terminated
- 2022-11-23
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Firm location
- Pennington, NJ
Drug identification
- Brand name(s)
- ACYCLOVIR
- Generic name(s)
- ACYCLOVIR
- Manufacturer(s)
- Zydus Pharmaceuticals (USA) Inc.
- NDC(s)
68382-048, 68382-049- Route(s)
- INTRAVENOUS