December 27, 2019
Lupin Pharmaceuticals Inc. is recalling two lots of memantine hydrochloride extended-release capsules, 28 mg, because samples failed to meet dissolution specifications during routine testing. The recall was included in the December 25, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects memantine hydrochloride extended-release capsules, 28 mg, in 90-count bottles (NDC 68180-249-09) and 500-count bottles (NDC 68180-249-02) from lots H901787 and H901788 (Exp. 3/21). The bottles were distributed throughout the United States.
Lupin Pharmaceuticals initiated the voluntary recall December 10, 2019. On December 23, 2019, the FDA designated the recall Class III. Under the recall classification, use of the affected capsules is not likely to cause harm.
Memantine hydrochloride is a prescription NMDA-receptor antagonist used to treat moderate-to-severe dementia associated with Alzheimer disease.