Drug 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.
D-0122-2021
Product summary
- Event
- Event 86749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,931 vials
- Official record key
drug-enforcement:D-0122-2021
Official wording
Reason: CGMP Deviations
Code information: Lot #s: 7S10115A, Exp. 07/31/2021; 7S10143A, 7S10182B, Exp. 09/30/2021; 7S10255A, 7S10256A, 7S10263A, Exp. 11/30/2021; 7T10028A, 12/31/2021; 7T10040A, Exp. 01/31/2022.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations