FDA Drug Class III — Least Serious

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

Hazard

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

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Products

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
Brand
Lupin Pharmaceuticals Inc.
UPC
Lot #: H901787, H901788, Exp March 2021

Units Affected

3,726 bottles

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