Valsartan Recall Expanded, FDA Investigating Products from Outside China

— Other ARB manufacturers subject to FDA investigation

by Nicole Lou, Staff Writer, �鶹��ý August 10, 2018

Last Updated August 16, 2018

This article is a collaboration between �鶹��ý and:

More valsartan products are under recall, according to an announcement from the FDA.

Added to the list of are valsartan-containing products manufactured by Hetero Labs Limited in India, labeled as Camber Pharmaceuticals in the U.S. However, not all Camber valsartan products distributed in the U.S. are being recalled, the agency noted in an .

The trouble stems from the discovery of N-nitrosodimethylamine (NDMA) impurities in the recalled Camber products. Hetero Labs makes the active pharmaceutical ingredient for these valsartan products using a process akin to that of Zhejiang Huahai Pharmaceuticals, the Chinese supplier to affected companies in the first round of valsartan recalls announced in mid-July.

NDMA is a probable human carcinogen, according to lab tests.

Hetero Labs tests show their valsartan has too much NDMA, albeit at levels that are generally lower than what was discovered in the active pharmaceutical ingredient manufactured by Zhejiang.

FDA is testing valsartan products for NDMA and working with other manufacturers of valsartan active pharmaceutical ingredient to see if they might be at risk of NDMA formation in their manufacturing processes. Additionally, the agency is investigating whether other angiotensin II receptor blockers are also at risk of NDMA contamination.

Warnings of NDMA impurities in valsartan first emerged in Europe and the United Kingdom in early July.

Nicole Lou is a reporter for �鶹��ý, where she covers cardiology news and other developments in medicine.