Story highlights The heart drug valsartan is being recalled in 22 countries

An external supplier introduced a chemical that might have a cancer link

(CNN) A common drug used to control blood pressure and help prevent heart failure is being recalled in 22 countries because it contains a chemical that poses a potential cancer risk.



Valsartan is off-patent and is used as a component of other generic medicines. Novartis, the company that originally developed the drug, said Sandoz valsartan and valsartan /HCT film-coated tablets are being recalled since they "do not meet our high quality standards." Pharmacies in the UK are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare.

The recall involves about 2,300 batches that were sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.

Novartis spokesman Eric Althoff said that products sold in the United States are not affected by this recall. Sandy Walsh, a spokeswoman for the US Food and Drug Administration said the agency is aware of the situation and "has no comment at this time," adding that the FDA is "committed to informing the public in a timely manner when the agency identifies safety issues. Generally, the agency does not comment on third-party announcements, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health."

The problem was discovered during tests of batches of valsartan's active pharmaceutical ingredient (API), as those from an external supplier contained an impurity. The European Medicines Agency reviewed medicines from the supplier, Zhejiang Huahai Pharmaceuticals in Linhai, China. The agency said the impurity is "a result of a change in the manufacturing process."

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