On Friday, July 13, 2018, The US Food and Drug Administration (FDA) has announced a voluntary recall of several drug products containing the medication valsartan because of an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. NDMA is classified as a probable human carcinogen 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 FDA said in a statement.
Valsartan is used to treat hypertension and heart failure. The following valsartan products are being recalled:
|Valsartan/Hydrochlorothiazide (HCTZ)||Solco Healthcare|
|Valsartan/Hydrochlorothiazide (HCTZ)||Teva Pharmaceuticals|
If you are on valsartan or valsartan/hydrochlorothiazide it should be replaced by another prescription if:
Please contact the health provider who prescribed the valsartan to get a prescription for a replacement. The name of the prescriber will be on the prescription bottle.
PLEASE NOTE: There is no immediate danger from the medication. The Food and Drug Administration recommends that you remain on the current medication until you get a replacement since continuing on this type of medication is important for your health.
If you have any other questions, please contact one of your health care providers, preferably the one who prescribed the medication.
Rutgers Health Group