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Dr. Reddy's recalling heartburn drug sold in US, says FDA

FP Archives March 13, 2014, 14:09:55 IST

While product recalls are not uncommon, the FDA announcement comes amid a string of quality problems for Indian drug makers, including ban on Sun pharma imports today.

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Dr. Reddy's recalling heartburn drug sold in US, says FDA

Mumbai: Generic drugmaker Dr. Reddy’s Laboratories Ltd is recalling about 58,656 bottles of the heartburn drug Lansoprazole in the United States due to a microbial contamination, the US Food and Drug Administration said. It was classified as a “Class II” recall which indicates a remote chance of severe adverse consequences or death due to the product flaw. [caption id=“attachment_921285” align=“alignleft” width=“380”] A file photo of a newly mechanized pharmaceutical machine that helps pharmacists dispense medicine is loaded with ARV medication. AP Representative Image. AP[/caption] Dr. Reddy’s voluntary recall of Lansoprazole delayed release capsules, a generic version of Swiss drugmaker Novartis’ drug Prevacid 24 HR, began on 3 January, 2014, the FDA said on its website. While product recalls are not uncommon, the FDA announcement comes amid a string of quality problems for Indian drug makers. In a weekly report, the US regulator also announced it was banning imports from Sun Pharmaceutical Industries Karkhadi manufacturing plant in Gujarat. Just last week, the FDA had disclosed that products made by Sun Pharma and Ranbaxy Laboratories were being recalled. A spokesman for Dr. Reddy’s was not immediately available to comment. Reuters

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