Drug product
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05.
D-0171-2023
Product summary
- Event
- Event 91442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2628 bottles
- Official record key
drug-enforcement:D-0171-2023
Official wording
Reason: Failed Dissolution Specification
Code information: Lot#: 21141321, 21141322, Exp 01/31/2023.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification