FDA recall D-1186-2014

Product

Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.

Reason for recall

Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-01-27

Report date

2014-04-09

Termination date

2015-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1186-2014