Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (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 27437-207-03.
Reported: April 9, 2014 Initiated: January 27, 2014 #D-1187-2014
Product Description
Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (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 27437-207-03.
Reason for Recall
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 5,172 bottles
- Distribution
- Nationwide
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (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 27437-207-03.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 5,172 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 9, 2014. Severity: Low. Recall number: D-1187-2014.
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