Urgent Medication Recall

Valsartan

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 is thought to be related to changes in the way the active substance was manufactured. The medication in question was made by 2 companies, Princeton PharmaceuticalsInc., and Major Pharmaceuticals. Patients on these medications are urged to make an appointment so that we can change your medication. Current FDA recommendations:

 

  • Because valsartan is used in medicines to treat serious medical  conditions, patients taking the recalled valsartan-containing medicines  should continue taking their medicine until they have a replacement  product.
  • To determine whether a specific product has been recalled,  patients should look at the drug name and company name on the label of  their prescription bottle. If the information is not on the bottle,  patients should contact the pharmacy that dispensed the medicine.
  • If a patient is taking one of the recalled medicines listed  below, they should follow the recall instructions provided by the  specific company. This information will be posted to the FDA’s website.
  • Patients should also contact their health care professional (the  pharmacist who dispensed the medication or doctor who prescribed the  medication) if their medicine is included in this recall to discuss  their treatment, which may include another valsartan product not  affected by this recall or an alternative treatment option.

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