US Drug Recall Register
Class III · Low risk Terminated Initiated Jan 27, 2014 (13 years ago)

Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

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.

Recalling firm
Lupin Pharmaceuticals Inc.
NDC code
27437-207-02
Origin
MD, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1186-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Cefixime recalls

See all