FDA – Torrent Pharmaceuticals Limited extends its recall for losartan potassium tablets USP and losartan potassium / hydrochlorothiazide tablets (USP) to the consumer due to the detection of traces of unexpected contamination in an active ingredient (API) manufactured by Hetero Labs Limited.
The recall will be extended by another 36 lots of Losartan Potassium Tablets USP and 68 lots of Losartan Potassium / Hydrochlorothiazide Tablets (USP)
The impurity detected in the API is N-methylnitrosobutyric acid (NMBA). Torrent is reminiscent of many Losartan-containing products that contain N-Methylnitrosobutyric Acid (NMBA) over the acceptable daily intake levels of the FDA.
To date, Torrent Pharmaceuticals Limited 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 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, USP, should continue to take their medications because the risk to the patient's health may be higher if treatment is stopped immediately without alternative treatment , Patients should consult their pharmacist or doctor, who can inform them about alternative treatment before returning their medication.
The products / lots included in the extended recall are listed in red below. The product can be identified by Check the product name, manufacturer's information, and the lot or lot number on the bottle containing these products.
The full FDA report can be found at: https://www.fda.gov/Safety/Recalls/ucm636296.htm