FDA-Drug2020-05-20Class III
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
The Harvard Drug Group
Hazard
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Sold states
AL, FL, IA, NY, OH, TX
Affected count
678 cartons
Manufactured in
17177 N Laurel Park Dr Ste 233, N/A, Livonia, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1262-2020Don't want to check this manually?
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