The FDA recently announced that they have expanded the valsartan recall to include some medications released by Hereto Labs Limited, labeled in the U.S. as Camber Pharmaceuticals.

On Aug. 9, the U.S. Food and Drug Administration (FDA) announced that it would be including Hetero Labs Limited products in their valsartan recall. Hetero Labs is an India based company which labels its products in the United States as Camber Pharmaceuticals Inc.

Although some of the company’s products have been included in the recall, not all Camber valsartan products available in the United States are involved in the valsartan recall. Hetero Labs reportedly manufacturers valsartan products in a process similar to Zhejiang Huahai Pharmaceuticals, a Chinese company included in the original valsartan recall notice.

“Hetero Labs manufactures the API for the Camber products using a process similar to Zhejiang Huahai Pharmaceuticals,” the valsartan recall announcement states. “Test results from Hetero Labs show the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang.”

This addition follows the July 13 announcement of the valsartan recall, voluntarily initiated by several companies after finding that their valsartan products may contain an impurity known as N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen and may be linked to the development of cancer.

The FDA is testing valsartan products for the presence of NDMA and has kept a running list of those products affected and those products not affected by the valsartan recall. The information remains available on the agency’s website where it posts regular updates.

“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA Commissioner Scott Gottlieb in the agency’s original press release.

“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. 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 United States with an adequate supply of unaffected medications.”

To date, companies involved in the valsartan recall include: Hetero Labs Limited (labelled as Camber Pharmaceuticals); Teva Pharmaceuticals (labelled as Major Pharmaceuticals and Actavis); Prinston Pharmaceuticals (labeled as Solco Healthcare LLC, A-S Medication Solutions LLC, AvKARE, and RemedyRepack); Bryant Ranch Prepack Inc.; H. J. Harkins Company Inc.; Lake Erie Medical (doing business as Quality Care Products LLC); NuCare Pharmaceutivals Inc.; Northwind Pharmaceuticals; and Proficient Rx.

Patients who have taken medications involved in the valsartan recall may be affected by the lapse in quality control. Although no lawsuits have been filed over the issue, and information is still forthcoming, patients may have legal grounds to hold manufacturers accountable for manufacturing and distributing potentially dangerous products.