Home / Recalls / Forest Pharmaceuticals Inc / D-1065-2014

D-1065-2014 Class III Terminated

Recalled by Forest Pharmaceuticals Inc — Earth City, MO

Recall Details

Product Type
Drugs
Report Date
February 12, 2014
Initiation Date
November 13, 2013
Termination Date
May 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
111,384 sample packs

Product Description

Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05.

Reason for Recall

Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

Distribution Pattern

Nationwide and Puerto Rico.

Code Information

Lot 1112467 Exp. 02/15

Other recalls by Forest Pharmaceuticals Inc

  • D-0036-2015 Class II — Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, (September 26, 2014)
  • 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-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)