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Valsartan Recall Expanded, FDA Investigating Products From Outside China

This story was originally published Aug. 10, 2018. As part of MedPage Today’s year-end review of 2018’s top stories, we are republishing it along with an update on what has happened since with contamination issues affecting valsartan and other angiotensin receptor blockers.

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

Added to the list of products under recall 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 updated statement.

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 that 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 U.K. in early July.