Drug product
Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29.
D-1064-2014
Product summary
- Event
- Event 66838
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,950 packs
- Official record key
drug-enforcement:D-1064-2014
Official wording
Reason: Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Code information: Lot 1113661 Exp. 01/15
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications