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US FDA adds Indian company's valsartan product to recall list

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US FDA adds Indian company's valsartan product to recall list

The U.S Food and Drug Administration updated its list of the recalled valsartan products to include the compound manufactured by India's Hetero Labs Ltd.

The agency disclosed the recalls in July after Chinese drugmaker Zhejiang Huahai Pharmaceutical Co. Ltd.'s valsartan products were found to have a cancer-causing impurity, N-nitrosodimethylamine, or NDMA.

Valsartan-containing drugs are widely used to treat high blood pressure and heart failure.

The U.S. FDA said NDMA found in Hetero's products, sold under the label of its unit Camber Pharmaceuticals Inc., exceeded acceptable levels but was lower than the those manufactured by Zhejiang.

The regulator said Hetero Labs and Zhejiang Huahai manufacture the drug using a similar process, which the FDA had earlier cited as the reason for the presence of the impurity.

The FDA said it has also contacted other producers of valsartan to check whether their manufacturing processes can also lead to the formation of NDMA.

The agency is also exploring whether other compounds belonging to the same class as valsartan, an angiotensin II receptor blocker, are also at risk of the presence of NDMA.

Angiotensin II receptor blockers help relax blood vessels, which lowers blood pressure and makes it easier for the heart to pump blood.

The other companies whose products are present on recall list include those made by Teva Pharmaceutical Industries Ltd., Major Pharmaceuticals Inc., Solco Healthcare, A-S Medication Solutions LLC, Bryant Ranch Prepack Inc., HJ Harkins Co. and Northwind Pharmaceuticals LLC.