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FDA Announces Recall of Valsartan-containing Products

FDA Announces Recall of Valsartan-containing Products

In addition to the Canadian recall, drugs containing valsartan have been recalled in 21 other countries because of contamination from the supplier: a Chinese company called Zhejiang Huahai Pharmaceutical.

Valsartan from Teva Pharmaceuticals Industries Ltd.

Three companies that sell the generic drug, valsartan, in the United States agreed to recall it after the FDA said might be tainted by N-nitrosodimethylamine (NDMA), considered a probable human carcinogen.

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.

Patients and doctors are being warned to ensure that the valsartan that they are taking is not being manufactured by this particular company.

Huahai customer Harbin Medisan Pharmaceuticals has also recalled valsartan dispersible tablets made using Huaihai ingredients.

"We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan sold by these specific companies does not meet our safety standards".

The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan 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.

The Chinese manufacturer of a widely used blood pressure medication said it had launched a global recall after United States and European regulators warned of contamination by a cancer-causing impurity.

If you don't know where you medication came from in the past, your pharmacy should have that information.

This recall is being conducted with the full knowledge of the U.S. FDA. Vulsartan is the commonly used medication used to treat high blood pressure and heart failure.

The FDA will continue to investigate this issue and provide additional information when it becomes available.

The Provincial Pharmacovigilance Centre Punjab issued an alert asking manufacturers to review their sources of raw materials of valsartan (a formula used in the making of hypertension medicines).

This incident raises serious questions regarding the quality methods employed by the Pakistan Pharmaceutical Manufacturing Industry (PPMI). "The voluntary recall showed the company's research and development competence has reached a certain level and it is being responsible", he said.

The FDA previously reported that imported medications and their ingredients may not have been evaluated for safety and effectiveness in the USA, even if they were legal in foreign countries.

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