Recalls / Class I
Class ID-0315-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Brand name
- Acyclovir
- Generic name
- Acyclovir
- Active ingredient
- Acyclovir Sodium
- Route
- Intravenous
- NDCs
- 68382-048, 68382-049
- FDA application
- ANDA206535
- Affected lot / code info
- Lot#: L000155, Exp 12/2021; L000156, Exp 1/2022
Why it was recalled
Crystallization: customer complaints for crystallization in finished product.
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 816 packs
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2021-02-18
- FDA classified
- 2021-03-30
- Posted by FDA
- 2021-04-07
- Terminated
- 2022-11-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0315-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.