Product: 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.
Recall initiated: 20191210
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated