Drug product
Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.
D-1412-2014
Product summary
- Event
- Event 68548
- Status
- Terminated
- Classification
- Class II
- Quantity
- 92,544 Bottles
- Official record key
drug-enforcement:D-1412-2014
Official wording
Reason: Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Code information: Lot # A308879, Expiry: 09/2015
Distribution pattern: Nationwide including Puerto Rico.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications