Drug product
Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
D-0129-2019
Product summary
- Event
- Event 81326
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53,451 bottles
- Official record key
drug-enforcement:D-0129-2019
Official wording
Reason: Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Code information: Lot # 1220211M, Exp 02/2019
Distribution pattern: U.S.A. Nationwide including Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out-of-Specification