The Harvard Drug Group recalls Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by:
Recalled May 20, 2020 · FDA recall D-1262-2020 · The Harvard Drug Group
Hazard
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing. · FDA Class III
Units
678 cartons
Sold at
AL, FL, IA, NY, OH, TX
Description
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
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
Manufacturer(s)
The Harvard Drug Group
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →