Huahai US, Inc. and Zhejiang Huahai Pharmaceutical Co., Ltd. have been hit with a proposed class action lawsuit that alleges the companies have manufactured, distributed and sold Valsartan generic prescription medications adulterated with N-nitrosodimethylamine (NDMA), a known carcinogen.
Filed in New Jersey district court, the 37-page lawsuit explains Valsartan is used mainly to treat high blood pressure and congestive heart failure. While generic drugs are supposed to be of equal quality and safety to their brand-name counterparts, the complaint alleges manufacturing defects at the defendants’ facility in China have led certain generic formulations of Valsartan to become tainted with NDMA, a substance toxic to the liver and believed to be cancer-causing in humans. Of the alleged problems at the defendants’ plant, the complaint states FDA inspectors found that equipment “was rusting and rust was being deposited into drug product,” in addition to “shedding cracking paint” finding its way into the drug as well.
According to the suit, the FDA announced a voluntary recall of several brands of Valsartan-containing generic medications due to the presence of NDMA.
“Adulterated Valsartan is essentially worthless,” the complaint reads. “No consumer would purchase an adulterated Valsartan product or is even allowed to purchase an adulterated Valsartan product because it was illegally introduced into the United States. This is especially so given that alternative, non-adulterated Valsartan products or competing medications with the same approved indications were available from other manufacturers.”