Fda Voluntary

On September 23, 2019, the FDA announced a voluntary recall of all lots of prescription ranitidine capsules. These acid-blocking medications are used to treat conditions such as ulcers, acid reflux, and esophagitis. Unfortunately, tests have revealed they may contain unacceptable levels of the contaminant N-Nitrosodimethylamine (NDMA). NDMA is a substance which may cause cancer in humans. Ranitidine, also known by the brand name Zantac, is also available over the counter for treating heartburn, acid reflux, and sour stomach.

5. What Is NDMA?

Ndma

Once a component of rocket fuel, United States manufacturers no long intentionally produce NDMA. According to the EPA, NDMA may be an unintended byproduct of chemical reactions in the course of synthesizing other products. Furthermore, NDMA is found in air, the water supply, and food products. The FDA maintains guidelines for the maximum allowable levels of this contaminant in food and medications.

4. The Discovery of Ranitidine Contamination

Ranitidine Contamination

According to Medscape Pharmacists, the first inkling of a possible impurity in ranitidine tablets came to light in June 2019. At that time, Swissmedic, the Swiss Health Authority, found traces of NDMA in Sandoz-manufactured ranitidine tablets. These levels were above those allowed by health authorities. Further testing prompted Sandoz to voluntarily recall certain lots of ranitidine hydrochloride capsules in both the 150mg and 300mg strengths. You can find the NDC and lot numbers for the recalled capsules on the Sandoz website.

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