FDAFDA · Food and drugs·Recall number D-0315-2021
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.
Published April 7, 2021 · Recall initiated: February 18, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization: customer complaints for crystallization in finished product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ACYCLOVIR
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- USA Nationwide
- Lot
- Lot#: L000155, Exp 12/2021; L000156, Exp 1/2022
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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