FDA recall D-1262-2020

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.

Distribution

AL, FL, IA, NY, OH, TX

Key facts

Status

Terminated

Initiation date

2020-04-24

Report date

2020-05-20

Termination date

2022-08-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1262-2020