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06

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FDA requires additional testing of ranitidine and nizatidine as part of agency’s ongoing effort to help ensure product safety for patients and consumers

Over the past several weeks, FDA has communicated about the detection of an impurity known as N-nitrosodimethylamine (NDMA) in common heartburn medications (ranitidine, commonly known as Zantac, and nizatidine) available over the counter or by prescription. We have launched an investigation to understand the cause of this impurity in these drugs and to provide information for patients and consumers who take them. As part of this investigation, we have asked manufacturers to conduct their own laboratory testing to examine levels of NDMA in ranitidine and nizatidine and to send us samples to be tested by our scientists....[FDA]

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