Pharmaceutical company Sandoz Inc. is voluntarily recalling losartan potassium hydrochlorothiazide (Losartan), as the pills may contain an impurity, 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 as per International Agency for Research on Cancer (IARC),” agency officials wrote in the Nov. 8 news release.
The recall involves 100 milligram/25 milligram Losartan tablets with the lot number JB8912 and expiration date of June 2020. The affected product was not distributed prior to Oct. 8, 2018, according to the FDA.
The agency recently recalled two other blood pressure drugs for the impurity, irbesartan and valsartan. Those who take these hypertension medications should consult with a doctor or pharmacist before discontinuing use of the drug.
The American Heart Association in January announced new guidelines that lowered the threshold for high blood pressure.
For decades, high blood pressure was determined with a top reading of at least 140 or a bottom one of 90. According to the new guidelines, a reading of 130/80 is considered high blood pressure, adding 30 million U.S. adults to the bucket of those with a condition that now affects nearly half of the U.S. adult population.