Torrent Pharma Expands Recall of Losartan Products Due to Impurities

By Patricia Van Arnum - DCAT Editorial Director

April 25, 2019

In the latest industry recall of “sartan”-containing products, Torrent Pharmaceuticals, an Ahmedabad, India-based pharmaceutical company, is expanding its recall for losartan potassium tablets USP and losartan potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-methylnitrosobutyric acid (NMBA), a potential human carcinogen.

The recall is expanded to include an additional 36 lots of losartan potassium tablets USP and 68 lots of losartan potassium /hydrochlorothiazide tablets, USP.

Torrent is only recalling lots of losartan-containing products that contain NMBA above the acceptable daily intake levels released by the US Food and Drug Administration (FDA).

To date (as of April 22, 2019), Torrent reports it 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 for the treatment of nephropathy in Type 2 diabetic patients. Losartan potassium and hydrochlorothiazide tablets, USP, is used to treat hypertension and hypertensive patients with left ventricular hypertrophy.

Recalls of “sartan”-containing products by multiple companies due to impurities arising in the manufacturing processes date back to 2018, which prompted both the FDA and the European Medicines Agency to further investigate these “sartan”-containing products, which are primarily used as anti-hypertensive and cardiovascular drugs. Previously, two other nitrosamine impurities, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), were found in drug products containing the APIs of valsartan, losartan and irbesartan and recalled with further investigation into other sartan products containing candesartan and olmesartan.

Source: Torrent Pharmaceuticals and FDA