FDA recall D-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

Reason for recall

Failed Dissolution Specification; at the 6-month stability time point

Distribution

Nationwide including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2014-09-26

Report date

2014-10-29

Termination date

2017-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Earth City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0036-2015