Recalls / Class III
Class IIID-1186-2014
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.
- Affected lot / code info
- Lot #s: F300737 Exp. February 2015, F300743 Exp. February 2015
Why it was recalled
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21st, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 4,038 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-01-27
- FDA classified
- 2014-04-02
- Posted by FDA
- 2014-04-09
- Terminated
- 2015-05-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1186-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.