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Notes
ARB = angiotensin type 2 receptor blocker
including the gas chromatography-mass spectrometry [GC/MS] headspace method; the combined headspace method; and the combined direct injection method
NDMA = N-nitrosodimethylamine; NDEA = N-nitrosodiethylamine
including amlodipine/valsartan tablets, valsartan tablets andvalsartan/hydrochlorothiazide tablets
including all lots of amlodipine/valsartan tablets and amlodipine/valsartan/hydrochlorothiazide tablets
Reference
US Food and Drug Administration. FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan. Internet Document : 12 Dec 2018. Available from: URL: https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm
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US FDA issues summary of recent updates for ARBs. Reactions Weekly 1733, 4 (2018). https://doi.org/10.1007/s40278-018-55803-7
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DOI: https://doi.org/10.1007/s40278-018-55803-7