D-0036-2015 Class II Terminated
FDA drug recall D-0036-2015 was initiated by Forest Pharmaceuticals Inc on September 26, 2014 and is designated Class II. Reason for recall: Failed Dissolution Specification; at the 6-month stability time point The recall status is terminated (terminated March 29, 2017). Affected quantity: 94,584 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- October 29, 2014
- Initiation Date
- September 26, 2014
- Termination Date
- March 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94,584 cartons
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
Reason for Recall
Failed Dissolution Specification; at the 6-month stability time point
Distribution Pattern
Nationwide including Puerto Rico.
Code Information
Lot A369286, exp. date 31 Jan 2016