Dr Reddy's Laboratories recalls 58,656 bottles of heartburn drug in US

Mar 14 2014, 11:10 IST
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Dr Reddy's step is classified as a 'Class II' recall, which indicates a remote chance of severe adverse consequences or death due to the product flaw. Dr Reddy's step is classified as a 'Class II' recall, which indicates a remote chance of severe adverse consequences or death due to the product flaw.
SummaryDr Reddy's step is classified as 'Class II' recall, indicating remote chance of severe adverse consequences due to product flaw.

Indian generic drugmaker Dr Reddys Laboratories 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.

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 announced it was 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 January 3, 2014, the FDA said on its website.

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

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