FDA-Drug2014-04-09Class III
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.
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
5,172 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, 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1187-2014Don't want to check this manually?
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