ScieGen is recalling certain lots of the angiotensin II receptor blocker (ARB) irbesartan because the tablets contain N-Nitrosodiethylamine (NDEA), a suspected human carcinogen.
The impurity was identified following laboratory testing conducted by the Food and Drug Administration (FDA); this is the first non-valsartan product that the Agency has found to contain NDEA.
A list of affected products can be found here. These products are labeled as Westminster Pharmaceuticals and Golden State Medical Supply. Additionally, the manufacturer that provides the active pharmaceutical ingredient (API) for ScieGen’s irbesartan products, Aurobindo, is recalling all unexpired lots of irbesartan API with NDEA supplied in the US.
Currently, only irbesartan products from ScieGen are affected by this recall; the FDA will continue to test ARBs for impurities, including Nitrosodimethylamine (NDMA), a probable human carcinogen identified in certain lots of valsartan products.
Irbesartan is indicated for the treatment of hypertension and for diabetic nephropathy in patients with type 2 diabetes and hypertension. Patients should be cautioned not to stop taking their medication until a pharmacist can provide replacement tablets or a clinician prescribes an alternative treatment.
To date, there have been no reports of adverse events related to this recall.
For more information visit FDA.gov.