US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 14, 2020 (6 years ago)

Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
Cipla
NDC code
69097-805-40
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0165-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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