(WIAT) – Torrent Pharmaceuticals Limited extends its recall for Losartan Potassium Tablets USP and Losartan Potassium / Hydrochlorothiazide Tablets (USP) to the Consumer due to detection of trace amounts of an unexpected contaminant in an active ingredient (API) manufactured by Hetero Labs Limited.
The recall was extended by another 36 lots of losartan potassium USP tablets and 68 batches of losartan potassium / hydrochlorothiazide tablets, USP.
The impurity detected in the API is N-methylnitrosobutyric acid (NMBA). Torrent only remembers many losartan-containing products that contain N-methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels of the FDA.
Torrent Pharmaceuticals Limited has not received any reports of adverse events in this regard.  Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy, and to treat nephropathy in type 2 diabetics. Losartan potassium and hydrochlorothiazide tablets, USP, is used to treat hypertension and hypertensive patients with left ventricular hypertrophy.
Patients taking losartan potassium tablets, USP and losartan potassium / hydrochlorothiazide tablets should continue to take the medicine The patient's health may be higher if the treatment is stopped immediately without alternative treatment. Patients should contact their pharmacist or doctor to inform them about alternative treatment before returning a drug.
The products / batches included in the extended recall are listed in red below. The product can be identified by by checking the product name, the manufacturer's instructions, and the batch or lot number on the bottle with these products.
To view the full FDA report: https://www.fda.gov/Safety/Recalls/ucm636296.htm