Product: Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61
Reason for recall: Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Recall initiated: 20200424
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated