Recalls / Class II
Class IID-1348-2014
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
- Brand name
- Bystolic
- Generic name
- Nebivolol Hydrochloride
- Active ingredient
- Nebivolol Hydrochloride
- Route
- Oral
- NDCs
- 0456-1402, 0456-1405, 0456-1410, 0456-1420
- FDA application
- NDA021742
- Affected lot / code info
- Lot: A287945, Exp: 08/2015
Why it was recalled
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.
Recalling firm
- Firm
- Forest Pharmaceuticals Inc
- Manufacturer
- Allergan, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 13600 Shoreline Dr, N/A, Earth City, Missouri 63045-1220
Distribution
- Quantity
- 21,875 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-05-12
- FDA classified
- 2014-05-22
- Posted by FDA
- 2014-05-28
- Terminated
- 2016-01-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1348-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.