LAKE CHARLES, LA (KPLC) - Torrent Pharmaceuticals Limited is expanding its voluntary recall of Losartan potassium tablets USP for the second time, according to the FDA.
The recall is expanding from 10 lots of Losartan potassium tablets USP to include six lots of Losartan potassium and hydrochlorothiazide tablets, USP due to detection of trace amounts of an unexpected impurity, FDA said. The products may contain N-nitrosodiethylamine, or NDEA, above the acceptable daily intake levels. NDEA has been classified as a probable human carcinogen.
The FDA 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 taking the medication should continue as the risk of harm to their health could be higher if discontinued without an alternative.
These tablets are sold nationwide. See a list of affected lots HERE.
Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall. Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at 1-800-912-9561.
See the second recall HERE.