Lupin Pharmaceuticals Inc. recalls Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceut…

Recall date

February 12, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0855-2020

FDA classification

Class II

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

Nationwide within the United States.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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