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, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.
D-0123-2021
Product summary
- Event
- Event 86749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,560 vials
- Official record key
drug-enforcement:D-0123-2021
Official wording
Reason: CGMP Deviations
Code information: Lot #: 7S10227A, Exp. 10/31/2021
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations