Alzheimer Med Recalled

The Harvard Drug Group is recalling 678 cartons of memantine hydrochloride extended-release capsules distributed in six states by Major Pharmaceuticals. According to the May 20, 2020, US Food and Drug Administration (FDA) Enforcement Report, the capsules failed to meet dissolution specifications during routine stability testing. 

The recall affects memantine hydrochloride extended-release capsules, 28 mg, 100 capsules per carton (NDC 0904-6735-61), from lots M02199D and M02246D (Exp. 5/20). The capsules were manufactured by Lupin Limited and distributed by Major Pharmaceuticals in Alabama, Florida, Iowa, New York, Ohio, and Texas. 

The Harvard Drug Group initiated the voluntary recall April 24, 2020. The FDA designated the recall Class III on May 13, 2020. Under the recall classification, use of the affected capsules is not likely to cause harm. 

Memantine is a prescription medication used to treat moderate to severe dementia associated with Alzheimer disease.

—Jolynn Tumolo