Drug product
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03
D-0451-2022
Product summary
- Event
- Event 89377
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,637 500-count bottles
- Official record key
drug-enforcement:D-0451-2022
Official wording
Reason: Failed Dissolution Specifications
Code information: Lots# 21141983, 21141984 and 21141985, Exp 03/31/2023; Lots# 21142017, 21142018, 21142019, Exp 02/28/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications