Drug product
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96
D-0191-2024
Product summary
- Event
- Event 89450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
drug-enforcement:D-0191-2024
Official wording
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Code information: Batch 2447J211
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations