A pharmaceutical company voluntarily recalls lots of Losartan potassium tablets after it has found an impured substance, which a cancer research agency classifies as a "probable human carcinogen."
Torrent Pharmaceuticals Limited recently released an announcement, which the Food and Drug Administration posted on its website, reminding the consumers that it was recalling Losartan medicines that were used to treat high blood pressure and nephropathy of Type 2 diabetics after tracing what was described as an "unexpected impurity."
This substance was in the active pharmaceutical ingredient from the manufacturer Hetero Labs Limited. Those affected have an expiration date of April 2019.
"The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes," the company said.
Impurity A Carcinogen
The NDEA was listed as a probable human carcinogen by the International Agency for Research on Cancer, the intergovernmental agency of the World Health Organization. This substance was the same found by Sandoz Inc. that prompted recalls of its Losartan as well.
As of writing, the pharmaceutical company said it has not received any complaints or reactions in line with the Losartan recall. Meanwhile, Torrent still advises those taking the medicine not to abruptly stop without an alternative medicine, as it could be harmful to the patients' health.
"Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication," it further said.
Details Of Recalled Losartan
Consumers should check the name of the product, manufacturer info, as well as batch or lot numbers indicated on the bottle if these match the following:
LOSARTAN POTASSIUM TAB, USP 100mg, 30-count bottles, lot/batch BO31C016
LOSARTAN POTASSIUM TAB, USP 100mg, 90-count bottles, lot/batch BO31C016
LOSARTAN POTASSIUM TAB, USP 100mg,1,000-count bottles, lot/batch 4DK3C005
Meanwhile, this is not the first time a blood pressure medicine has been recalled for containing substance that could cause cancer. Just in late November, two more drugs, amlodipine and valsartan, were asked to be returned after the company, Teva Pharmaceuticals, found NDEA on these.
Photo: Scott Feldstein | Flickr