Monday, March 17, 2014

Heartburn Drug Recalled Over Microbial Contamination

Indian 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 U.S. Food and Drug Administration says.

It was classified as a "Class II" recall which indicates a remote chance of severe adverse consequences or death due to the product flaw.

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 U.S. regulator also announces it is banning imports from Sun Pharmaceutical Industries Ltd. Karkhadi manufacturing plant in the western state of Gujarat. And just last week, the FDA disclosed that products made by Sun Pharma and Ranbaxy Laboratories Ltd. were being recalled.

Dr. Reddy's voluntary recall of lansoprazole delayed release capsules, a generic version of Swiss drugmaker Novartis' drug Prevacid 24 HR, began on Jan. 3, 2014, the FDA says on its website.

A spokesman for Dr. Reddy's was not immediately available to comment to Reuters.

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