In July of 2018, the U.S. Food and Drug Administration (FDA) announced a for several lots of valsartan-containing products due to contamination with the possible carcinogen N-nitrosodimethylamine (NDMA). The list of recalled products has as more companies producing angiotensin II receptor blockers (ARBs) in the same class as valsartan, including products containing losartan and irbesartan, have discovered lots of drugs contaminated with NDMA or N-nitrosodiethylamine (NDEA). Patients prescribed the affected products should not spontaneously discontinue treatment with these medications, as the risk of harm to the patients' health may be higher if the treatment is stopped immediately without any alternative treatment. While the FDA's investigation is ongoing, the ACC is actively working to keep members up-to-date on the latest information. Click the following links to review updated lists of,,.
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In a 2018, Randall M. Zusman, MD, FACC, director of the division of hypertension at the Massachusetts General Hospital Heart Center, mapped his institution's response to the ever-expanding list of recalled drugs within this class and areas of improvement for the future identification of contaminated products. Updates: Torrent Further Expands Voluntary Recall of Losartan (1/23/2019) Torrent Pharmaceuticals is further expanding its to include six additional lots of losartan potassium and hydrochlorothiazide combination tablets, for a total of 16 lots of losartan-containing medicines. This recall is due to unacceptable amounts of NDEA in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing medication containing NDEA above the interim acceptable intake limits of 0.27 parts per million. Aurobindo Pharma, Torrent Pharmaceuticals Adds to ARB Recalls (1/3/2019) Aurobindo Pharma USA, Inc.
And Torrent Pharmaceuticals Limited announced voluntary recalls for select lots of and, respectively, due to contamination with the possible carcinogen NDEA. These announcements are added to a for potentially contaminated ARBs. Super fdisk 10 bootable iso download torrent. FDA Presents Interim Limits of Nitrosamines in Currently Marketed ARBs () The FDA is publishing interim acceptable intake levels of nitrosamine impurities in ARBs for manufacturers to use to ensure their finished drug products are safe for patients. The agency evaluated safety data for the probable human carcinogens N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) to determine an interim acceptable intake level for these impurities in the ARB class. See the full. FDA Updates Recalls For Valsartan, Losartan and Irbesartan (12/4/2018) The FDA expanded the to all lots of non-expired valsartan-containing products, including 104 additional lots containing amlodipine and valsartan tablets, valsartan tablets and valsartan and hydrochlorothiazide.