Home / Recalls / Forest Pharmaceuticals Inc / D-0036-2015

D-0036-2015 Class II Terminated

Recalled by Forest Pharmaceuticals Inc — Earth City, MO

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

Other recalls by Forest Pharmaceuticals Inc

  • D-1412-2014 Class II — Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, (June 19, 2014)
  • D-1348-2014 Class II — Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed fro (May 12, 2014)
  • D-1065-2014 Class III — Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packa (November 13, 2013)
  • D-1064-2014 Class III — Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extend (November 13, 2013)
  • D-1063-2014 Class III — Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx (November 13, 2013)