FDA-Drug2020-12-23Class II

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

CIPLA
Hazard

cGMP deviations: Vials may not be sealed correctly affecting sterility.

Sold states
USA Nationwide
Affected count
2151 vials
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0165-2021

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