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India's Lupin Recalls 10,000 Bottles of Suprax in the U.S.

April 14, 2014

antibiotic fails to meet U.S. standards for impurities

Lupin Pharmaceuticals Inc., based in Baltimore, MD has recalled 10,000 bottles of the antibiotic Suprax made by its Indian parent company, Lupin Ltd., after failing to meet U.S. standards for impurities. The recall was initiated on January 27 but made public by the U.S. FDA this week. Suprax is used to treat bacterial infections of the ear and upper respiratory tract.
 
"This is a voluntary recall initiated on our own and of no business consequence," according to a Lupin spokesman in India.
 
As the second-largest supplier of generic drugs in the U.S., the U.S. FDA has increased its scrutiny of Indian pharmaceutical companies the past few years and has since uncovered numerous quality issues.
 
Lupin joins India's Ranbaxy Laboratories Ltd. and Sun Pharmaceutical Industries Ltd. for recent product recalls, including 480,000 bottles of generic versions of the cholesterol drug Lipitor in the U.S. due to glass particles found in some bottles, and Sun Pharma’s recall of thousands of bottles of generic diabetes medication in the U.S. after some bottles were found to contain drugs meant to treat epilepsy.

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