The FDA has determined that the impurity in some ranitidine products increases over time and at higher temperatures and may result in dangerous levels N-Nitrosodimethylamine (NDMA). This substance is likely a human carcinogen (cancer causing).
The high levels of NDMA found in Zantac are unsafe and were consumed for years by unsuspecting consumers, even though the makers of Zantac knew about these risks.
The FDA has requested that manufacturers withdraw all prescription and over-the-counter ranitidine drugs from the market immediately. Prompted by information from third-party laboratories, the FDA determined that NDMA levels increase significantly in samples, even under normal storage conditions.
More than 15 million Americans take ranitidine at prescription levels andmillions more take a lower-dose, over-the-counter version. At one point, Zantac was the best-selling drug in the world.
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