Drug 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.
D-1186-2014
Product summary
- Event
- Event 67462
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,038 bottles
- Official record key
drug-enforcement:D-1186-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Code information: Lot #s: F300737 Exp. February 2015, F300743 Exp. February 2015
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications