FDA provides update on its ongoing investigation into valsartan products, identifies second impurity

FDA issued Thursday an update on its ongoing investigation regarding the recent voluntary recall of several drug products containing the active pharmaceutical ingredient (API) valsartan. The agency's latest tests indicate there is an additional unexpected impurity in three lots of Torrent Pharmaceuticals' recalled valsartan products.

FDA issued Thursday an update on its ongoing investigation regarding the recent voluntary recall of several drug products containing the active pharmaceutical ingredient (API) valsartan. The agency's latest tests indicate there is an additional unexpected impurity in three lots of Torrent Pharmaceuticals' recalled valsartan products. That impurity, N-Nitrosodiethylamine (NDEA), is a known animal and suspected human carcinogen. The affected Torrent products were part of the company's recall on August 23, 2018. After learning that Zhejiang Huahai Pharmaceuticals (ZHP) found NDEA in several batches of its valsartan API, FDA retested all valsartan API and products for that impurity. Thus far, the agency has discovered NDEA in some of ZHP's valsartan API as well as in the three Torrent lots, which were made using API from ZHP. Not all products made using ZHP valsartan API contain NDEA, FDA noted. "As we continue to investigate the root cause of the impurities found in products that contain valsartan, our scientists are testing these products to better understand these impurities and to ensure they're not present in other products. We're also taking steps to make sure we're providing stringent oversight of manufacturing processes to reduce the likelihood that impurities could be introduced into other products," said FDA Commissioner Scott Gottlieb, MD. FDA reminded patients taking valsartan from a recalled lot to keep taking their current medication until their doctor or pharmacist offers a replacement or a different treatment option. The agency said, "At this time, the FDA's testing supports the conclusion that not all valsartan products contain NDMA or NDEA, so pharmacists may be able to provide a valsartan medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition."