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Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
On July 13, 2018, FDA announced a voluntary recall of products containing the API valsartan because the impurity N-nitrosodimethylamine (NDMA) was found in some products that contain the API, which was manufactured from a third-party supplier. Teva Pharmaceuticals Industries Ltd., Major Pharmaceuticals, and Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. are recalling all lots of non-expired valsartan-containing products supplied by this third-party supplier. FDA is investigating the levels of NDMA in the products and the possible effect on patients. Not all products containing valsartan are being recalled, as not all companies use the same API supplier.
According to FDA, NDMA is classified as a probable human carcinogen. The presence of NDMA “was unexpected and is thought to be related to changes in the way the active substance was manufactured.” The API supplier has stopped the distribution of its valsartan, and the affected companies are working with FDA to reduce or eliminate the impurity from future products.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a press release.