UPDATE on angiotensin II receptor blocker (ARB) recalls: Torrent further expands its voluntary recall of losartan; FDA posts new nitrosamine testing methods- Drug Information Update

Torrent Pharmaceuticals Limited is further expanding its voluntary recall to include 104 additional lots of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets. This recall is due to unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in the losartan active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The agency updated the list of losartan products under recall accordingly. FDA reminds patients taking recalled angiotensin II receptor blockers (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. FDA is also posting new testing methods which can help manufacturers and international regulators detect and identify multiple nitrosamine impurities. FDA and international regulators have identified N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and NMBA in ARBs. A direct injection GC-MS method that is able to detect NDMA, NDEA, N-Nitrosodiisopropylamine (NDIPA), N-Nitrosoethylisopropylamine (NEIPA), and N-nitrosodibutylamine (NDBA) A headspace GC-MS method that is able to detect NDMA, NDEA, NDIPA, and NEIPA These methods should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission. For more information, please visit: FDA Updates on ARB Recalls.