Drug product
AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10
D-1134-2017
Product summary
- Event
- Event 77948
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1212 bottles
- Official record key
drug-enforcement:D-1134-2017
Official wording
Reason: PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Code information: Lot #: 6142626, Exp 09/19
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Foreign material or chemical contamination
FOREIGN TABLETS