Forest Pharmaceuticals Inc recalls Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license
Recalled May 28, 2014 · FDA recall D-1348-2014 · Forest Pharmaceuticals
Hazard
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. · FDA Class II
Units
21,875 bottles
Sold at
Nationwide and Puerto Rico
Description
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.
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
Manufacturer(s)
Forest Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →