Drug 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
D-0036-2015
Product summary
- Event
- Event 69298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 94,584 cartons
- Official record key
drug-enforcement:D-0036-2015
Official wording
Reason: Failed Dissolution Specification; at the 6-month stability time point
Code information: Lot A369286, exp. date 31 Jan 2016
Distribution pattern: Nationwide including Puerto Rico.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification