FDAFDA · Food and drugs·Recall number D-1348-2014
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
Published May 28, 2014 · Recall initiated: May 12, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BYSTOLIC
- Manufacturer
- Forest Pharmaceuticals Inc
- Distributor
- Nationwide and Puerto Rico
- UPC
- 0304561405909
- Lot
- Lot: A287945, Exp: 08/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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