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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: A287945, Exp: 08/2015
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1348-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 12, 2014
- FDA report date
- May 28, 2014
- Quantity
- 21,875 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Forest Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1348-2014, exactly as published.
Show all FDA fields
- City
- Earth City
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 68246
- Address
- 13600 Shoreline Dr
- Code information
- Lot: A287945, Exp: 08/2015
- Postal code
- 63045-1220
- Report date
- May 28, 2014
- Product type
- Drugs
- Recall number
- D-1348-2014
- Classification
- Class II
- Recalling firm
- Forest Pharmaceuticals Inc
- Product quantity
- 21,875 bottles
- Termination date
- Jan 5, 2016
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- May 12, 2014
- Initial firm notification
- Letter
- Center classification date
- May 22, 2014