Drug product
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
D-0485-2026
Product summary
- Event
- Event 98672
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0485-2026
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # N02425, Exp Date: 05/31/2027.
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications