Home / Recalls / Lupin Pharmaceuticals Inc. / D-0629-2020

D-0629-2020 Class III Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

Recall Details

Product Type
Drugs
Report Date
December 25, 2019
Initiation Date
December 10, 2019
Termination Date
April 29, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,726 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: H901787, H901788, Exp March 2021

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