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August 16, 2018

FDA expands voluntary heart drug recall, citing potential cancer risk

Daily Briefing

    FDA has expanded its voluntary recall of several medications commonly used to treat heart failure and high blood pressure, citing an impurity in the products that could cause cancer.

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    Recall details

    FDA in July announced a voluntary recall of several drugs containing the active ingredient valsartan, though the agency noted that not all products containing valsartan were subject to the recall.

    Products subject to the recall contain an impurity known as N-nitrosodimethylamine (NDMA), which FDA said "is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests." The agency added, "The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured."

    The products subject to FDA's initial recall are:

    • Valsartan produced by Major Pharmaceuticals;
    • Valsartan and Valsartan/Hydrochlorothiazide produced by Solco Healthcare; and
    • Valsartan and Valsartan/Hydrochlorothiazide produced by Teva Pharmaceuticals.

    Since July, FDA has twice expanded the voluntary recall to include additional drugs containing valsartan and valsartan/hydrochlorothiazide that are produced by:

    • AvKARE;
    • Bryant Ranch Prepack;
    • Camber Pharmaceuticals;
    • HJ Harkins Company;
    • Northwind Pharmaceuticals;
    • NuCare Pharmaceuticals;
    • Proficient Rx; and
    • Remedy Repack.

    Sandy Walsh, a media contact at FDA, said, "Valsartan-containing drug products with active pharmaceutical ingredients supplied by the affected manufacturer make up nearly 43% of the U.S. market share of valsartan-containing drug products since January 2018."

    FDA has said it is still evaluating the impurity's potential effect on patients who have been taking the affected drugs and is looking into whether it is possible to reduce or eliminate the impurity from future batches of the affected drugs.

    What patients taking valsartan-containing drugs should do

    FDA said patients can determine whether their medications are affected by the recall by identifying the drug's name and manufacturer. If a patient's medication is affected, he or she should follow the specific recall instructions for the drug provided by the drug's manufacturer, which FDA will post on its website.

    FDA said affected patients also should contact either the physician who prescribed the drug or the pharmacist who dispensed the drug to discuss their future treatment plan, which could include taking another valsartan product that is not affected by the recall. FDA said patients taking the affected medications should continue taking them until they can obtain a replacement product (Snider, USA Today, 8/7; NBC Chicago, 8/7; Welch, CBS News, 8/7; Guinness, ABC News, 8/7).

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