Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Phar...
FDA Recall #D-1063-2014 — Class III — November 13, 2013
Product Description
Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33
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
156 bottles
Distribution
Nationwide and Puerto Rico.
Code Information
Lot 1111291 Exp. 02/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated