FDA recall D-0855-2020

Product

Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06

Reason for recall

Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.

Distribution

Nationwide within the United States.

Key facts

Status

Terminated

Initiation date

2020-02-12

Report date

2020-02-19

Termination date

2021-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0855-2020