Health Advisory
FDA ANNOUNCES VOLUNTARY RECALL OF SEVERAL MEDICINES CONTAINING VALSARTAN FOLLOWING DETECTION OF AN IMPURITY

The Delaware Division of Public Health (DPH) is issuing this health advisory to provide the health care community with information from the U.S. Food and Drug Administration (FDA). The FDA is alerting providers and patients of a voluntary recall of several drug products containing the active ingredient valsartan. Valsartan is used to treat high blood pressure and heart failure.

Summary

The FDA is alerting health care providers and patients of a voluntary recall of several drug products containing the active ingredient valsartan. Valsartan is 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 companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. The supplier has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.

Recalled Products

Recommendations/Reporting

•  Contact patients to whom you have prescribed, or dispensed, valsartan products included in this recall to discuss their treatment. Discussion on how to proceed with treatment in light of the recall may include switching patients to another valsartan product not affected by this recall or choosing an alternative treatment option.
•  Because valsartan is used in medicines to treat serious medical conditions, advise patients taking the recalled valsartan-containing medicines to continue taking their medicine until they have a replacement product.
•  To determine whether a specific product has been recalled, instruct patients to 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, instruct them to follow the recall instructions provided by the specific company. This information will be posted to the FDA's website.

Additional Information

•  The FDA will continue to investigate this issue and provide additional information when it becomes available. The agency encourages patients and health care professionals to report any adverse reaction to the FDA's MedWatch program.
•  FDA Press Release - https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm
•  FDA Drug Recall List - https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm
•  MedWatch (report adverse reactions) - https://www.fda.gov/Safety/MedWatch/default.htm

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