FDA-Drug2021-04-07Class I
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.
Zydus Pharmaceuticals (USA) Inc
Hazard
Crystallization: customer complaints for crystallization in finished product.
Sold states
USA Nationwide
Affected count
1,638 packs
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0316-2021Don't want to check this manually?
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