Torrent Pharmaceuticals Ltd has said it is voluntarily recalling 16 batches of losartan potassium tablets from the US market due to an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by the city-based Hetero Labs Limited.
According to an announcement made by Torrent to the US Food and Drug Administration on January 22, the impurity detected in the API is N-nitrosodiethylamine (NDEA).
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.
“Torrent is only recalling lots of losartan containing products that contain Nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.
To date, Torrent Pharmaceuticals has not received any reports of adverse events related to this recall,” it said.
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, the communication said.