Drug product
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61
D-1262-2020
Product summary
- Event
- Event 85566
- Status
- Terminated
- Classification
- Class III
- Quantity
- 678 cartons
- Official record key
drug-enforcement:D-1262-2020
Official wording
Reason: Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Code information: Lot #: M02199D, M02246D, Exp 5/2020
Distribution pattern: AL, FL, IA, NY, OH, TX
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications