Why it was recalled
Failed Dissolution Specification; at the 6-month stability time point
Product description
Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07
Lot numbers, UPCs & expiration codes
Lot A369286, exp. date 31 Jan 2016
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-0036-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 26, 2014
- FDA report date
- Oct 29, 2014
- Quantity
- 94,584 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Forest Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0036-2015, exactly as published.
Show all FDA fields
- City
- Earth City
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 69298
- Address
- 13600 Shoreline Dr
- Code information
- Lot A369286, exp. date 31 Jan 2016
- Postal code
- 63045-1220
- Report date
- Oct 29, 2014
- Product type
- Drugs
- Recall number
- D-0036-2015
- Classification
- Class II
- Recalling firm
- Forest Pharmaceuticals Inc
- Product quantity
- 94,584 cartons
- Termination date
- Mar 29, 2017
- Reason for recall
- Failed Dissolution Specification; at the 6-month stability time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07
- Distribution pattern
- Nationwide including Puerto Rico.
- Recall initiation date
- Sep 26, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 17, 2014