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Valsartan API impurity Leads to Recall of Some Products

Very seldom do we see a notice of recall that relates to a change in the manufacture or processing of the Active Pharmaceutical Ingredient (API), but that is what appears to have happened in this instance.  The FDA announcement states:

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.  This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products.  However, not all products containing valsartan are being recalled.  NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.  The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

The full notice can be found here, which also identifies the companies involved in the recall.  Not all companies’ products are affected by this voluntary recall because the drug product manufacturers likely have different suppliers of the API.

The FDA is continuing its investigation of this issue and will report its findings on its web page.  The notice also advises patients that may have taken or are taking valsartan or valsartan/hydrochlorothiazide that they should not discontinue the product because it is used to treat a serious health issue, but should contact their healthcare provider to determine the best course of action so treatment can be continued.  The FDA also notes that it is “working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”  Stay tuned!