Drug product
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
D-0354-2026
Product summary
- Event
- Event 98348
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,780 bottles
- Official record key
drug-enforcement:D-0354-2026
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot#: a) 0715J251, Exp.: 12/2026; 0716J251, Exp.: 01/2027; 0717J251, Exp.: 01/2027; b) 0715J252, Exp.: 12/2026; 0716J252, Exp.: 01/2027, 0717J252, Exp.: 01/2027.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications