Sandoz announced a voluntary recall of 1 lot of Losartan Potassium and Hydrochlorothiazide Tablets 100mg/25mg due to trace amounts of N-nitrosodiethylamine (NDEA) found in the active pharmaceutical ingredient (API) losartan.
NDEA has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC). The losartan API was manufactured by Zhejiang Huahai Pharmaceuticals Co. Ltd. The combination product, Losartan Potassium and Hydrochlorothiazide is manufactured by Lek Pharmaceuticals dd, in Ljubljana, Slovenia.
Losartan Potassium and Hydrochlorothiazide Tablets are approved to treat hypertension, alone or in combination with other antihypertensive drugs. The recall affects the 100mg/25mg strength tablets in 1000-count bottles with Lot #JB8912 and Expiration Date 06/2020. The affected product was distributed nationwide after October 8, 2018. Those in possession of the recalled product should immediately discontinue distribution and quarantine any remaining supply.
This recall adds to the growing list of angiotensin II receptor blockers being recalled for containing potentially carcinogenic impurities. In previous months, both valsartan and irbesartan products have been subjected to recalls.
For more information call (800) 525-8747 or visit Sandoz.com.