Chinese drug maker recalls valsartan products in USA over impurity

Chinese drug maker recalls valsartan products in USA over impurity

Chinese drug maker recalls valsartan products in USA over impurity

The agency is telling that traces of N-nitrosodimethylamine (NDMA) "probable human carcinogen", was found in the active ingredient valsartan in the recalled products.

Major Pharmaceuticals is committed to patient safety and is partnering with the Food and Drug Administration (FDA) to notify customers who may be in possession of Valsartan tablets supplied by Teva Pharmaceuticals.

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The EMA said NDMA was an unexpected impurity that was not detected by routine tests carried out by Zhejiang Huahai, adding that the manufacturing changes introduced in 2012 were believed to have produced NDMA as a by-product. Also, the FDA said there is a link between valsartan and cancer. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine. Solco and Teva were also asked to recall their drugs containing valsartan/hydrochlorothiazide (HCTZ).

Valsartan is off patent and is used as a component of other generic medicines, but not all medicines containing the ingredient are involved, according to the FDA.

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To determine if a specific product has been recalled, look at the drug name and company name on the prescription bottle's label. This information will be posted to the FDA's website.

Zhejiang Huahai, which was founded in 1989 and listed on the Shanghai stock exchange in 2003, was one of the first Chinese companies to get drugs approved in the USA market.

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Scott Gottlieb said "The FDA is committed to maintaining our gold standard for safety and efficacy". FDA is assuring the public that they are investigating with their proper efficiency and they will find out all the products which are creating the bad impacts. That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured. When contacted, DRAP deputy director (quality control) Abdul Sattar Sohrani confirmed the recall orders and said the pharmaceutical firms concerned had been given one week to remove from the market the medicines made from Zhejiang Huahai's valsartan. This is raising concerns among the people about what medications can be used without causing further deterioration to the patients. According to Harry Lever, a cardiologist at the Cleveland Clinic, "It's not just valsartan".

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