The Food and Drug Administration (FDA) has issued a recall for a blood pressure medication that may contain a chemical classified as a carcinogen (cancer-causing chemical).
According to a release, Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg. This product is being recalled due to the trace amount of an impurity known as N-nitrosodiethylamine (NDEA). This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen.
To date, Sandoz Inc. has not received any reports of adverse events related to this lot.
Losartan Potassium Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension (high blood pressure). It may be used alone or in combination with other antihypertensive agents.
The product can be identified as Losartan Potassium Hydrochlorothiazide, 100 mg/25 mg tablets in 1000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020.
This product was distributed nationwide to distributors. The affected product was not distributed prior to October 8, 2018.
The FDA says patients who are on this medication should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Losartan Potassium Hydrochlorothiazide.
For more info, visit the FDA’s website.