FDA recall D-264-2013

Product

Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.

Reason for recall

Discoloration; Product may not meet specifications for color description once reconstituted.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-01-31

Report date

2013-04-24

Termination date

2013-09-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-264-2013