Product: 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, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726  NDC 72485-201-01.
Reason for recall: CGMP Deviations
Recall initiated: 20201208
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated