D-1348-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 28, 2014
- Initiation Date
- May 12, 2014
- Termination Date
- January 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,875 bottles
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot: A287945, Exp: 08/2015