Levels of NDMA, a carcinogen, were found to increase over time and when stored at high temperatures.
The FDA is looking into the presence in ranitidine of NDMA , a substance that may cause cancer in humans. While many of the samples tested did not contain"unacceptable levels" of NDMA, the FDA found that levels of the substance may increase over time and especially when stored at temperatures higher than room temperature. This could lead, they concluded, to consumers being exposed to unacceptable levels of the carcinogen.
"Since we don't know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a press release. According to the FDA, low levels of NDMA are present foods and water and are commonly ingested.
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