FDA-Drug2014-05-28Class II

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

Forest Pharmaceuticals Inc
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.

Sold states
Nationwide and Puerto Rico
Affected count
21,875 bottles
Manufactured in
13600 Shoreline Dr, N/A, Earth City, MO, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1348-2014

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