Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 681...
FDA Recall #D-0629-2020 — Class III — December 10, 2019
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.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
3,726 bottles
Distribution
Nationwide in the USA
Code Information
Lot #: H901787, H901788, Exp March 2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated