Torrent Pharmaceuticals is expanding its recall of losartan potassium tablets from 2 lots to 12 lots, according to a Safety Alert from the Food and Drug Administration.
The recall was based on the discovery of N-nitrosodiethylamine (NDEA) above recommended levels in seven 100-mg lots of losartan, four 50-mg lots, and one 25-mg lot. NDEA is a naturally occurring substance that has been classified as a probable human carcinogen by the International Agency for Research on Cancer. Torrent Pharmaceuticals has not reported any adverse events related to the recall.
Losartan currently is indicated to treat hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in type 2 diabetic patients. Patients who are taking losartan should continue to do so, as stopping treatment without an alternative could represent a greater health risk.
“Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication,” the FDA said in the press release.
Find the full press release on the FDA.