FDA recall D-0844-2020

Product

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61

Reason for recall

Failed Dissolution Specifications: High out of specification result observed at stability studies.

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2019-12-13

Report date

2020-02-26

Termination date

2020-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0844-2020