Torrent Pharmaceuticals is expanding its voluntary recall to include five additional lots of losartan potassium tablets (three lots of losartan potassium tablets and two lots of losartan potassium/hydrochlorothiazide (HCTZ) combination tablets). The recall is due to unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited. Torrent is recalling lots of losartan-containing medication that tested positive for NMBA above 9.82 parts per million.
The agency updated the list of recalled angiotensin II receptor blockers (ARBs) accordingly.
FDA reminds patients taking recalled ARBs to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition.
Torrent Pharmaceuticals has headquarters in Ahmedabad, India, and most operations centers are in India.
The September 2019 FDA notice of recall is the sixth product recall of losartan by Torrent Pharmaceuticals, this time with certain batches of losartan contained the contaminant, N-methylnitrosobutyric acid (NMBA), above acceptable daily intake levels determined by the FDA.
In 2018, Torrent Pharmaceuticals recalled tablets containing valsartan and losartan due to the detection of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) respectively which are probable human carcinogens. The FDA advised that the risk was very low.
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