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FDA Announces Recall

On July 13, 2018 the FDA announced a voluntary recall of several medicines containing valsartan, a medicine used to treat high blood pressure and heart failure.

On September 13, 2018, the FDA reported finding an additional carcinogenic impurity in one firm’s already recalled products. The U.S. Food and Drug Administration (FDA) said that three lots of Torrent Pharmaceuticals’ valsartan drugs have NDEA, known to cause cancer in animals and is believed to be carcinogenic to humans.

This recall is due to an impurity, N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API), which was found in the recalled products manufactured by Zhejiang Huahai Pharmaceuticals, Zhejiang Tianyu Pharmaceutical and Hetero Labs Limited. NDMA is one chemical in a class called “genotoxic impurities”. These chemicals are of special concern to global regulators because, unlike most impurities in drugs, they have the potential to cause harm at very low levels. The Environmental Protection Agency classifies NDMA as a probable human carcinogen and says exposure to high levels of NDMA may cause liver damage. The presence of NDMA is thought to be related to changes in the way the active substance was manufactured. The contamination may have been happening since 2012. This is the largest Class I FDA recall involving a pharmaceutical drug.

NDMA, an organic chemical that forms in both industrial and natural processes, has been used to make liquid rocket fuel, softeners and lubricants, among other products. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing. Zhejiang Huahai said NDMA was introduced when it changed its manufacturing process. The company made about 44 percent of the active ingredient for valsartan drugs sold between January and August 2018.

How Can We Help?

If you have been diagnosed with liver damage, tumors or cancer and you believe the damage was caused by contaminated valsartan blood pressure medications, you may be able to obtain compensation for your injuries. Call Bowersox Law Firm, P.C. right away for a free consultation.