Drug product
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.
D-0393-2022
Product summary
- Event
- Event 89411
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9216 bottles
- Official record key
drug-enforcement:D-0393-2022
Official wording
Reason: Failed Dissolution Specifications.
Code information: Lot #: 21143093, Exp. March 2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications