D-1348-2014 Class II Terminated
FDA drug recall D-1348-2014 was initiated by Forest Pharmaceuticals Inc on May 12, 2014 and is designated Class II. 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. The recall status is terminated (terminated January 5, 2016). Affected quantity: 21,875 bottles.
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