FDAFDA · Food and drugs·Recall number D-1186-2014
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.
Published April 9, 2014 · Recall initiated: January 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide
- Lot
- Lot #s: F300737 Exp. February 2015, F300743 Exp. February 2015
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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