Blood Pressure Medications Recalled Due to the Presence of Nitrosamines

The US Food and Drug Administration (FDA) announced a voluntary recall of several drug products that contain the blood pressure and heart failure medicines valsartan, losartan, and irbesartan. The voluntary recall was initiated in July 2018 when the impurity N-nitrosodimethylamine (NDMA) was identified in valsartan, and was updated in September 2018 when another impurity, N-nitrosodiethylamine (NDEA), was similarly detected. The recalls were expanded when NDEA was also detected in formulations of losartan and Irbesartan. Both NDMA and NDEA are considered probable carcinogens. Additional information regarding the recall timeline and status can be found on the FDA’s website, as accessed here.

CIL offers stable isotope labeled and native nitrosamine standards to assist laboratories with their testing needs.

Nitrosamines