Published: Fri, July 20, 2018
Medicine | By Melba Vasquez

Chinese drug maker recalls valsartan products in USA over impurity

Chinese drug maker recalls valsartan products in USA over impurity

The specific products impacted are valsartan sold by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries, along with valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals.

Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries Ltd. are the three companies recalling valsartan.

The U.S. Food and Drug Administration (FDA) has announced a voluntary recall of several blood pressure medications that may contain an impurity known as N-nitrosodimethylamine (NDMA), a probable human carcinogen (a substance that could cause cancer).

Worryingly, because valsartan is used to treat serious medical conditions such as blood pressure, patients taking drugs containing the active component can not simply stop taking their medication.

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Patients are advised to talk to their doctor if they are taking the medication.

The ingredient was supplied by a third-party.

To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle.

A request for a class-action suit filed in the Montreal courthouse on Monday wants the manufacturers of a recalled heart medication, valsartan, to pay damages to Quebecers who took the drug. The agency is still investigating, but said the contamination was believed to be related to changes in the way that valsartan was manufactured.

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The FDA advises that patients contact pharmacists or physicians for advice on alternate therapy in lieu of the recalled treatment.

Valsartan is described as an angiotensin-II-receptor antagonist used to treat hypertension, recent heart attack and heart failure. She's also upset that the FDA's advice to people who use the drugs is to keep using it until they find an alternative.

Not all valsartan-containing medications are part of this recall. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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The list of recalled products includes Cinfaval and Co-cinfaval manufactured by Spanish Cinfa Laboratories, as well as Diostar and Diostar plus manufactured by Jordan's Pharma International Co.

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