A pharmaceutical company is voluntarily expanding its recall of blood pressure medication after detecting trace amounts of a cancer-causing chemical.
Torrent Pharmaceuticals Limited announced it is expanding its recall of two lots of Losartan potassium tablets USP to a total of 10 lots, because the products contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.
NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification, according to the FDA.
To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.
Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients.
Patients who are on Losartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.
Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
For more information, visit the FDA website.