Drug product
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61
D-0844-2020
Product summary
- Event
- Event 84955
- Status
- Terminated
- Classification
- Class III
- Quantity
- 246 Cartons
- Official record key
drug-enforcement:D-0844-2020
Official wording
Reason: Failed Dissolution Specifications: High out of specification result observed at stability studies.
Code information: Lot# M02465D
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Potency or specification failure
out of specification