US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 8, 2020 (6 years ago)

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

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

Why it was recalled

CGMP Deviations

What was recalled

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.

Recalling firm
Shilpa Medicare Limited
NDC code
72606-558-01
Origin
N/A, India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0123-2021

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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