According to The United States Food and Drug Administration (FDA) media release on 8th Nov, 2018, Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets (USP 100mg/25mg) with the lot number JB8912, Exp. Date 06/2020. This is due to an impurity, N-nitrosodiethylamine (NDEA), found in the active pharmaceutical ingredient Losartan that could cause cancer. NDEA is an organic chemical, classified as probable human carcinogen, as per International Agency for Research on Cancer (IARC). This substance occurs naturally in certain foods, drinking water, air pollution, and industrial processes (e.g. pesticide manufacture, fish processing). This recall encompasses less than 1% of the national losartan drug products. Still today no report of adverse events related to the drug is reported.
Losartan Potassium Hydrochlorothiazide Tablets, USP are being prescribed by physicians for the treatment of hypertension either alone or in combination with other antihypertensive agents. It is recommended to consult a pharmacist or physician before discontinuing use of this drug for medication of hypertension. Discontinuation may be very risky to the patients until they have an alternative medication.