Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured...
FDA Recall #D-0855-2020 — Class II — February 12, 2020
Product Description
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
Reason for Recall
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6,294 bottles
Distribution
Nationwide within the United States.
Code Information
Lot #: H900330, exp. date 11/2020.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated