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Lupin Pharmaceuticals Inc. recalls Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-co

Recalled December 25, 2019 · FDA recall D-0629-2020 · Lupin Pharmaceuticals

Hazard
Failed Dissolution Specifications: High out of specification result observed at stability studies. · FDA Class III
Units
3,726 bottles
Sold at
Nationwide in the USA

Description

Failed Dissolution Specifications: High out of specification result observed at stability studies.

Product
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA
Manufacturer(s)
Lupin Pharmaceuticals Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Lupin Pharmaceuticals Inc. recalls Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-co | RecallWatchUSA