Torrent Pharmaceuticals Limited expanded its recall again for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets to include the consumer lever after trace amounts of an unexpected impurity was found in the active drug ingredient.
The drug ingredient was manufactured by Hetero Labs Limited, the Food and Drug Administration said in a news release.
The recall has already been expanded before, and now includes 36 more lots of Losartan Potassium tablets and 68 more lots of Losartan Potassium/Hydrochlorothiazide tablets.
Torrent has not received any reports of adverse reactions related to the recall so far, the FDA said.
Losartan is used to treat high blood pressure, or hypertension, as well as hypertensive patients with Left Ventricular Hypertrophy (LVH). It's also used to treat nephropathy in Type 2 diabetic patients. The tablets with hydrochlorothiazide are used to treat hypertension and hypertensive patients with LVH.
A full list of the lots with batch numbers and expiration dates is available here.