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.
Recall initiated: 20140127
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated