Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (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 27437-207-03.

Recall Number: D-1187-2014

Firm: Lupin Pharmaceuticals Inc.

Classification: Class III

Status: Terminated

Report Date: 20140409

Initiation Date: 20140127

Termination Date: 20150512

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

Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (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 27437-207-03.