CIPLA recalls Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa
Recalled December 23, 2020 · FDA recall D-0165-2021 · CIPLA
Hazard
cGMP deviations: Vials may not be sealed correctly affecting sterility. · FDA Class II
Units
2151 vials
Sold at
USA Nationwide
Description
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Product
Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40
Manufacturer(s)
CIPLA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →