D-1186-2014 Class III Terminated
FDA drug recall D-1186-2014 was initiated by Lupin Pharmaceuticals Inc. on Jan 27, 2014 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station. The recall status is terminated (terminated May 12, 2015). Affected quantity: 4,038 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 9, 2014
- Initiation Date
- Jan 27, 2014
- Termination Date
- May 12, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,038 bottles
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Distribution Pattern
Nationwide
Code Information
Lot #s: F300737 Exp. February 2015, F300743 Exp. February 2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1186-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026