Drug product
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
D-1063-2014
Product summary
- Event
- Event 66838
- Status
- Terminated
- Classification
- Class III
- Quantity
- 156 bottles
- Official record key
drug-enforcement:D-1063-2014
Official wording
Reason: Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Code information: Lot 1111291 Exp. 02/16
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications