Aurobindo Pharma USA has recalled 80 lots of medications containing the angiotensin-receptor blocker (ARB) valsartan because of the level of N-nitrosodiethylamine (NDEA) detected in the products. The recall includes two lots of valsartan alone, 26 lots of valsartan combined with amlodipine, and 52 lots of valsartan combined with hydrochlorothiazide.
Separately, Torrent Pharmaceuticals expanded its recall of another ARB, losartan, over NDEA levels. The company has now recalled 10 lots.
NDEA is a known carcinogen in animals and a suspected carcinogen in humans. Numerous ARB-containing medications began being recalled last summer over the presence of another impurity, N-nitrosodimethylamine (NDMA) — classified as a probable carcinogen.
List of Valsartan products under recall.
Source: NEJM Journal Watch
