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-0169-2023
Product summary
- Event
- Event 91442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49,632 bottles
- Official record key
drug-enforcement:D-0169-2023
Official wording
Reason: Failed Dissolution Specification
Code information: Lot #s: 21143094, 21143095, 21143119, 21143121, 21142389, Exp 03/31/2023.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification