Reported Apr 9, 2014 · Terminated
Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21st · Baltimore, MD · 21202-6174
Is this the product you have?
- 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.
- Lot codes and dates
Lot #s: F300737 Exp. February 2015F300743 Exp. February 2015
- Amount recalled
- 4,038 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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