FDA-Drug2014-04-09Class III
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.
Lupin Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Sold states
Nationwide
Affected count
4,038 bottles
Manufactured in
111 S Calvert St Fl 21st, N/A, Baltimore, MD, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1186-2014Don't want to check this manually?
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