Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sa...
FDA Recall #D-1065-2014 — Class III — November 13, 2013
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.
Recalling Firm
Forest Pharmaceuticals Inc — Earth City, MO
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
111,384 sample packs
Distribution
Nationwide and Puerto Rico.
Code Information
Lot 1112467 Exp. 02/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated