Losartan Potassium Tablets
Date of Recall: December 20, 2018
Recalling Firm(s): Torrent Pharmaceuticals Limited
Product: Losartan potassium tablets
Scope of recall: BO31C016 ( both 30 & 90 count bottles), 4DK3C005, 4DK3C004, 4DU3C040, 4DU3E049, 4DU3E050, 4L67C035, 4L67C035, 4L67C036, 4O50C005 and 4O49C013. See below.
Description: Torrent has voluntarily recalled ten lots of Losartan potassium tablets due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient manufactured by Indian pharmaceutical company Hetero Labs Limited. The impurity detected is N-nitrosodiethylamine (“NDEA”) — a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes. NDEA has been classified as a probable human carcinogen by the International Agency for Research on Cancer (“IARC”). Torrent reports that it 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. According to the FDA, 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.
For more information, please see the safety announcement posted on the FDA website. https://www.fda.gov/Safety/Recalls/ucm628966.htm.