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July 16, 2018

FDA recalls valsartan drug products after impurity detection

The US Food and Drug Administration (FDA) has announced a voluntary recall of multiple drug products containing valsartan as the active ingredient due to detection of an impurity called N-nitrosodimethylamine (NDMA).

The US Food and Drug Administration (FDA) has announced a voluntary recall of multiple drug products containing valsartan as the active ingredient following the detection of an impurity called N-nitrosodimethylamine (NDMA).

NDMA, which is considered as a potential human carcinogen, is believed to have been found in the products due certain changes in manufacture of the active ingredient.

The recalled products include those produced and marketed by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries.

FDA Center for Drug Evaluation and Research director Janet Woodcock said: “We have carefully assessed the valsartan-containing medications sold in the US and we’ve found that the valsartan sold by these specific companies does not meet our safety standards.

“This is why we’ve asked these companies to take immediate action to protect patients.”

The regulator noted that not all valsartan drugs in the US are being recalled and it is continuing the review and is assessing the NDMA levels in the recalled products to determine their effect on patients.

“We’ve found that the valsartan sold by these specific companies does not meet our safety standards.”

In addition, the FDA intends to establish measures to minimise or remove NDMA from future batches.

FDA commissioner Scott Gottlieb said: “As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the US with an adequate supply of unaffected medications.”

Earlier this month, the regulatory authorities of Ireland and the UK announced a similar recall of valsartan containing drugs manufactured by Dexcel Pharma and Accord Healthcare.

The FDA, the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA) and Irish Health Products Regulatory Authority (HPRA) have advised patients to not stop using the valsartan medication and consult their doctor for a replacement product.

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