Lupin Recalls Suprax in the U.S.
Indian drugmaker Lupin Pharmaceuticals is voluntarily recalling three lots of its flagship cephalosporin oral antibiotic Suprax after the drug failed to meet specification in total impurities at the nine-month stability mark.
The affected lots, in 5,172 bottles, were manufactured in Mumbai; all three are set to expire in February 2015.
The Class III recall was posted to the FDA’s website this month. Class III recalls involve product defects or quality issues that are not likely to cause adverse health consequences.
The FDA approved the first oral suspension of Suprax (cefixime) in 2007 to treat bacterial infections of the chest, ears, throat and urinary tract. This is not Lupin’s first recall of Suprax. In April 2013, the drugmaker recalled three lots — 64,368 bottles — of the drug over concerns about discoloration. — Lena Freund
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