Drug product
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.
D-0125-2021
Product summary
- Event
- Event 86749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4166 bottles
- Official record key
drug-enforcement:D-0125-2021
Official wording
Reason: CGMP Deviations
Code information: Lot #s: 7S10032A, 7S10034A, Exp. 02/28/2021
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations