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Valsartan impurities put millions of patients at risk of serious drug injuries. The FDA’s July 2018 recall of valsartan affects several major pharmaceutical manufacturers and distributors in the US.
Valsartan, is an FDA-approved medication used to treat high blood pressure & heart failure, and to reduce the risk of fatality after a heart attack. Valsartan works by loosening constricted blood vessels so that blood can flow more freely. Valsartan is used on its own or as valsartan HCTZ. In July 2018, the FDA initiated a voluntary recall of several pharmaceuticals containing valsartan manufactured in China due an impurity that can cause serious health issues for patients.
The volunteer recall initiated by the FDA in July includes valsartan manufactured by the Chinese company, Zhejiang Huahai Pharmaceuticals. In 2012 Zhejiang Huahai Pharmaceuticals changed its manufacturing method in a manner that caused the production of an impurity, known as N-nitrosodimethylamine (NDMA), as a byproduct. NDMA is a substance linked to higher risk for cancer among other health issues, including liver damage. Aside from recall in the US, valsartan has been recalled in 22 other countries.
Not all of the valsartan products on the market in the United States were produced by Zhejiang Huahai Pharmaceuticals. The recall only affects those manufacturers and distributors that incorporated the contaminated batches of valsartan into their final product. The manufacturers, distributors and labels affected by the recall include:
Click here for the FDA's complete list of products and lot numbers affected.
About NDMA
NDMA can be a dangerous substance and is used as an additive for lubricants and as a softener for copolymers. It was also used in making rocket fuels. . The EPA classifies NDMA as a B2 (probable human) carcinogen. If you have been taking a recalled valsartan product and you experience the following symptoms, you may be a victim of NDMA poisoning:
Long term exposure of the NDMA contaminated valsartan products can cause liver damage and cancer of the liver, kidney, and lungs.
What to do if you suspect NDMA poisoning
Legal liability
Legal liability against a manufacturer or distributor of a valsartan product is likely to be based on Texas' product liability laws. A lawsuit might allege, for example, that the manufacturer was negligent due to failure to exercise appropriate quality control over raw materials that it received from China.
Texas personal injury law allows an victims injured by drugs to recover losses arising from a negligent act including:
If you or a loved one has taken a valsartan product contaminated by NDMA and have been diagnosed with liver damage, tumors, or cancer, contact a Dallas valsartan drug injury attorney at Rasansky Law Firm for a free evaluation of your potential product liability case. At Rasansky Law Firm, we work on contingency – No Fees unless you win your case.
Note: The information that was utilized in this post was gathered from the use of secondary sources. This information used has not been confirmed or independently verified. If you locate any information that is not correct, please contact our firm as soon as possible so that we can make the appropriate corrections. If you find any information that is false, we will remove or correct the post immediately after it is brought to our attention.
Disclaimer: As a valued member of the Dallas community, Rasansky Law Firm’s goal is to improve the safety of all residents in the great state of Texas. These posts should not be viewed as a solicitation for business and the information included herein should not be taken as medical or legal advice. The photos used in this post are not representative of the actual crash scene.
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