FDA recall D-1127-2017

Product

Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01

Reason for recall

CGMP Deviations

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-05-02

Report date

2017-09-13

Termination date

2018-03-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1127-2017