FDA continues to investigate the presence of impurities in valsartan and other angiotensin II receptor blockers (ARBs) used to treat high blood pressure and heart failure. FDA has identified the impurities N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in ARB active pharmaceutical ingredient (API) and finished drugs. Medicines with confirmed levels of NDMA or NDEA exceeding the interim acceptable intake limits have been recalled because they pose an unacceptable safety risk to patients.
FDA is posting additional test results showing NDMA and NDEA levels in recalled valsartan. The analyses reflect average levels of the impurities present in a single tablet based on the strength of the tested medicines within the lots tested, which are identified in the table. The annoucement provides NDMA and NDEA levels and indicates where impurities either were not present or were below the limit of detection (LOD) of our testing method. Some of the medicines listed below may have been repackaged by other companies as noted in FDA’s list of recalled ARBs.
For more information, please visit: Valsartan
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