Multi event Drug Recall Enforcement Report Class III voluntary initiated by Forest Pharmaceuticals Inc, originally initiated on 11-13-2013 for the 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. The product was recalled due to failed dissolution specifications: three lots of product being recalled having failed stability dissolution testing.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1065-2014 | 11-13-2013 | 02-12-2014 | Class III | 111,384 sample packs | 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. | Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. | Terminated |
| D-1064-2014 | 11-13-2013 | 02-12-2014 | Class III | 3,950 packs | 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. | Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. | Terminated |
| D-1063-2014 | 11-13-2013 | 02-12-2014 | Class III | 156 bottles | 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 | Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. | Terminated |
Recalled Products
