FDA recall D-0684-2018

Product

Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202

Reason for recall

Superpotent Drug

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-03-27

Report date

2018-04-25

Termination date

2019-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0684-2018