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

Medicine	Company
Valsartan	Major Pharmaceuticals
Valsartan	Solco Healthcare
Valsartan	Teva Pharmaceuticals Industries Ltd.
Valsartan w/Hydrochlorothiazide (HCTZ)	Solco Healthcare
Valsartan w/Hydrochlorothiazide (HCTZ)	Teva Pharmaceuticals Industries Ltd.

Recommendations/Reporting

•  Contact patients to whom you have prescribed, or dispensed, valsartan productsincluded 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 patientsto 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, instructthem 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 informationwhen 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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