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Dr. Reddy's, Perrigo join in recall of ranitidine over impurity

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Dr. Reddy's, Perrigo join in recall of ranitidine over impurity

India's Dr. Reddy's Laboratories Ltd. initiated a voluntary recall of its ranitidine medicines in the U.S. market due to the confirmed contamination of a potential cancer-causing impurity called N-Nitrosodimethylamine, or NDMA.

The Indian drugmaker said in an Oct. 23 press release that the recall — which was initiated Oct. 1 — follows a warning issued by the U.S. Food and Drug Administration in September regarding the presence of NDMA in ranitidine, which is used to treat heartburn associated with acid indigestion and sour stomach.

Dr. Reddy's added that it has not received any reports of adverse events related to the recall of the company's ranitidine products.

Dr. Reddy's is the latest in a line of drugmakers to pull ranitidine medications off the shelves. Sanofi, which markets ranitidine as Zantac, has recalled the medicine in the U.S. and Canada, while Teva Pharmaceutical Industries Ltd., GlaxoSmithKline PLC, Mylan NV and Novartis AG have also recalled their generic ranitidine medicines following concerns expressed by the U.S. FDA, Health Canada and the European Medicines Agency.

Later on Oct. 23, Perrigo Company PLC also announced a worldwide recall of its ranitidine products due to the NDMA impurity. The Irish company said it began testing its ranitidine products after the FDA and other regulators flagged the concern, halting shipments Oct. 8. Perrigo has now opted to move forward with a recall based on the data collected.