Drug product
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.
D-1065-2014
Product summary
- Event
- Event 66838
- Status
- Terminated
- Classification
- Class III
- Quantity
- 111,384 sample packs
- Official record key
drug-enforcement:D-1065-2014
Official wording
Reason: Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Code information: Lot 1112467 Exp. 02/15
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications