Why it was recalled
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Product description
Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.
Lot numbers, UPCs & expiration codes
Lot # A308879, Expiry: 09/2015
Where it was sold
Nationwide including 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-1412-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 19, 2014
- FDA report date
- Jul 9, 2014
- Quantity
- 92,544 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Forest Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1412-2014, exactly as published.
Show all FDA fields
- City
- Earth City
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 68548
- Address
- 13600 Shoreline Dr
- Code information
- Lot # A308879, Expiry: 09/2015
- Postal code
- 63045
- Report date
- Jul 9, 2014
- Product type
- Drugs
- Recall number
- D-1412-2014
- Classification
- Class II
- Recalling firm
- Forest Pharmaceuticals Inc
- Product quantity
- 92,544 Bottles
- Termination date
- Jan 5, 2016
- Reason for recall
- Failed Dissolution Specifications: Drug failed stage III dissolution testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.
- Distribution pattern
- Nationwide including Puerto Rico.
- Recall initiation date
- Jun 19, 2014
- Initial firm notification
- Letter
- Center classification date
- Jun 30, 2014