Zydus Pharmaceuticals (USA) Inc recalls Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRI
Recalled April 7, 2021 · FDA recall D-0316-2021 · Zydus Pharmaceuticals (USA)
Hazard
Crystallization: customer complaints for crystallization in finished product. · FDA Class I
Units
1,638 packs
Sold at
USA Nationwide
Description
Crystallization: customer complaints for crystallization in finished product.
Product
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.
Manufacturer(s)
Zydus Pharmaceuticals (USA) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →