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

Recall Number: D-0855-2020

Firm: Lupin Pharmaceuticals Inc.

Classification: Class II

Status: Terminated

Report Date: 20200219

Initiation Date: 20200212

Termination Date: 20210603

Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.

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