FDA-Drug2020-02-26Class III
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
The Harvard Drug Group
Hazard
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Sold states
U.S.A. Nationwide
Affected count
246 Cartons
Manufactured in
17177 N Laurel Park Dr Ste 233, Livonia, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0844-2020Don't want to check this manually?
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