Recalls / Class II
Class IID-1412-2014
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.
- Affected lot / code info
- Lot # A308879, Expiry: 09/2015
Why it was recalled
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Recalling firm
- Firm
- Forest Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 13600 Shoreline Dr, Earth City, Missouri 63045
Distribution
- Quantity
- 92,544 Bottles
- Distribution pattern
- Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2014-06-19
- FDA classified
- 2014-06-30
- Posted by FDA
- 2014-07-09
- Terminated
- 2016-01-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1412-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.