Drug product
Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30
D-1348-2014
Product summary
- Event
- Event 68246
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21,875 bottles
- Official record key
drug-enforcement:D-1348-2014
Official wording
Reason: Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.
Code information: Lot: A287945, Exp: 08/2015
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications