What is NDMA and Why is It in Many Recalled Drugs?
On April 15, 2020, the U.S. Food and Drug Administration posted a notice on its website that a Nizatidine Oral Solution 15 mg/mL product was recalled due to containing high levels of nitrosodimenthylamine (NDMA). The product is manufactured by Amneal Pharmaceuticals, LLC, and distributed by its subsidiary Gemini Laboratories, LLC.
NDMA is classified as a probable human carcinogen, and it’s found both in the environment and in water and various food products, including meats, dairy products, and vegetables. Through 2018 and 2019, multiple brands of valsartan, a medication used to treat high blood pressure, were recalled due to containing the impurity. In 2019, recalls were initiated for various brands of ranitidine, including Zantac, an over-the-counter and prescription drug designed to treat heartburn and acid reflux.
Because NDMA is in many naturally occurring products and substances, its presence alone isn’t enough for a product to be recalled. Various governments and safety agencies have established thresholds for acceptable amounts of NDMA before products must be recalled. For example, the U.S. Environmental Protection Agency says that the maximal admissible concentration of NDMA in drinking water is 7 ng/L.
It’s important to continue to watch for drug recalls, as NDMA is being found in more and more common and household prescription and OTC medications. It’s especially important if you take daily medications and they’re found to contain high levels of NDMA, as cancer risks increase with frequent or daily usage over the course of many years.