Home / Recalls / The Harvard Drug Group / D-1262-2020

D-1262-2020 Class III Terminated

Recalled by The Harvard Drug Group — Livonia, MI

Recall Details

Product Type
Drugs
Report Date
May 20, 2020
Initiation Date
April 24, 2020
Termination Date
August 19, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
678 cartons

Product Description

Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61

Reason for Recall

Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.

Distribution Pattern

AL, FL, IA, NY, OH, TX

Code Information

Lot #: M02199D, M02246D, Exp 5/2020

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