Certain generic valsartan medicine stocks have been reportedly contaminated with NDMA, which reportedly increases the risk of liver, rectal, and other cancers.

This alleged contamination spurred one of the largest drug recalls in the history of the United States, with numerous patients already filing legal action against certain generic drug manufacturers, according to American Legal News.

The contaminated valsartan medication stocks reportedly stemmed from a Zhejiang Huahai Pharmaceuticals plant in China. The company allegedly contaminated the drugs during the manufacturing process.

NDMA (N-nitrosodimethylamine) is a lubricant that is typically produced as a side effect of a manufacturing process. The production of the substance reportedly started occurring when Zhejiang Huahai made changes to its manufacturing process several years ago.

This means that contaminated valsartan stocks could have been available in the United States for several years.

Valsartan is often prescribed to treat high blood pressure and hypertension, reducing the risk of potentially fatal cardiovascular problems.

Approximately one out of every 10 prescription medications sold in the United States is sourced from China, but the FDA allegedly failed to keep up the overseas inspections of different production facilities. According to Bloomberg News, FDA inspections fell by approximately 11 percent in 2017 to just 125 in total.

In addition, problems noted by inspectors can be overruled by management, leading to a potentially dangerous situation for consumers. In 2017, the FDA inspector reportedly determined some drugs from a Zhejiang Huahai plant may not have met United States safety standards and found evidence indicating that the company had falsified safety reports.

The inspector had recommended that a formal warning letter be sent to the plant to improve their manufacturing standards, or else they will not be allowed to sell any drugs in the United States.

However, FDA management reportedly overrode this concern, and Zhejiang Pharmaceuticals has since avoided penalties and had been allowed to make those production updates without FDA supervision.

It was discovered a year later that the affected valsartan medications were contaminated with NDMA.

Overview of Valsartan Recall

The FDA first announced the valsartan recall in July 2018 and had asked three generic manufacturers to voluntarily recall their stocks from the United States market.

Pharmacists were asked to take potentially contaminated medications out of their inventories and return them to their respective manufacturers. It is important to note that not all valsartan medicine products have been affected by the contamination, and the FDA is continuing to investigate.

Along with Zhejiang Huahai, it has been discovered that Hetero Labs Limited in India and Mykan Pharmaceutical Company may have also sourced allegedly contaminated valsartan medication to United States consumers. The valsartan recall specifically applies to medications distributed by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries.

European health officials also reported on the blood pressure drug contamination in May 2018, with the European Medicines Agency announcing that potentially dangerous contamination could be in certain valsartan medication stocks stemming from Zhejiang Huahai Pharmaceuticals.

For both European and American consumers, the exact amount of valsartan medicine contaminated by NDMA is not known. However, it is currently estimated that 743,000 people have taken the medication and approximately 1,800 of these patients reportedly developed cancer.