FDA-Drug2020-02-19Class II
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06
Lupin Pharmaceuticals Inc.
Hazard
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Sold states
Nationwide within the United States.
Affected count
6,294 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0855-2020Don't want to check this manually?
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