Lupin Recalls Certain Lots of Antibiotic Suprax

By Pharma News - DCAT Publisher

April 15, 2014

Lupin Pharmaceuticals Inc., Baltimore, has initiated a nationwide voluntary recall of 9,210 bottles of its antibiotic Suprax (cefixime) for oral suspension USP 500 mg/5 ml, 10 mL (when reconstituted), precscription only, The Class III recall was initiated on January 27, 2014 but posted to the FDA website in its enforcement report of April 9, 2014. The reason for the recall was failed impurities/degradation specifications in that the product did not meet specification in total impurities at the nine-month stability station. The drug is manufactured by Lupin Limited, Mumbai, India.

The recall applies to 4,038 bottles (Lot #s: F300737 Exp. February 2015, F300743 Exp. February 2015) and 5,172 bottles (Lot #s: F300736 Exp. February 2015, F300740 Exp. February 2015, F300741 Exp. February 2015).

A Class III recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Source: FDA (D-1187-2014 notice) and FDA (D-1186-2014 notice)