Recalls / Class II
Class IID-0036-2015
Product
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
- Affected lot / code info
- Lot A369286, exp. date 31 Jan 2016
Why it was recalled
Failed Dissolution Specification; at the 6-month stability time point
Recalling firm
- Firm
- Forest Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 13600 Shoreline Dr, Earth City, Missouri 63045-1220
Distribution
- Quantity
- 94,584 cartons
- Distribution pattern
- Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2014-09-26
- FDA classified
- 2014-10-17
- Posted by FDA
- 2014-10-29
- Terminated
- 2017-03-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0036-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.