FDA recall D-1412-2014

Product

Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.

Reason for recall

Failed Dissolution Specifications: Drug failed stage III dissolution testing.

Distribution

Nationwide including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2014-06-19

Report date

2014-07-09

Termination date

2016-01-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Earth City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1412-2014