The U.S. Food and Drug Administration (FDA) has banned all imports of drugs and drug products from Zhejiang Huahai Pharmaceutical, which manufactured valsartan, a high blood pressure medication that had a possible carcinogenic impurity.

In July 2018, the FDA and European Medicines Agency (EMA) supported a voluntary recall of lots of the generic blood pressure drug valsartan after it was discovered that the drugs were tainted with N-nitrosodimethylamine, or NDMA, which is an impurity that is considered a possible carcinogen by the U.S. Environmental Protection Agency (EPA). NDMA can be unintentionally introduced into manufacturing through certain chemical reactions.

Continue Reading FDA Bans Zhejiang Huahai Pharmaceutical Import as Valsartan Recall Continues

A recent class action was filed in New York against the companies responsible for distributing or selling drugs containing tainted valsartan. The lawsuit, brought by a woman and her husband, alleges negligence, fraud, and manufacturing a defective product, among other claims. It is expected that personal injury claims may soon follow.

Continue Reading Valsartan Class Action Filed