Drug product
Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01
D-1112-2015
Product summary
- Event
- Event 71316
- Status
- Terminated
- Classification
- Class II
- Quantity
- 889 bottles
- Official record key
drug-enforcement:D-1112-2015
Official wording
Reason: Failed Dissolution Specifications: OOS result during stability testing
Code information: Lot #: 34019710A, Exp 5/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications