Recall: D-0315-2021

Class I - Dangerous

Class IClassification

2021-02-18Initiated

TerminatedStatus

Zydus Pharmaceuticals (USA) InFirm

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

Crystallization: customer complaints for crystallization in finished product.

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.