FDA-Drug2026-04-22Class II
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
The Harvard Drug Group LLC
Hazard
Failed Dissolution Specifications
Sold states
US Nationwide.
Affected count
N/A
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0485-2026Original summary
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 Failed Dissolution Specifications Lot # N02425, Exp Date: 05/31/2027. Distribution: US Nationwide. Affected quantity: N/A
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