FDA recall D-0629-2020

Product

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-12-10

Report date

2019-12-25

Termination date

2021-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0629-2020