D-1412-2014 Class II Terminated
FDA drug recall D-1412-2014 was initiated by Forest Pharmaceuticals Inc on June 19, 2014 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Drug failed stage III dissolution testing. The recall status is terminated (terminated January 5, 2016). Affected quantity: 92,544 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 9, 2014
- Initiation Date
- June 19, 2014
- Termination Date
- January 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92,544 Bottles
Product Description
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.
Reason for Recall
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Distribution Pattern
Nationwide including Puerto Rico.
Code Information
Lot # A308879, Expiry: 09/2015