The FDA has recently released a voluntary recall of several drug products containing the active ingredient valsartan. These medications are primarily used to treat high blood pressure and heart failure. 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.
Why is it being recalled?
The FDA identified a cancer-causing impurity within the recalled products based on laboratory test results. They believe the impurity is a result of the way the active substance was manufactured. Due to this, not all products containing valsartan are being recalled.
What products are recalled?
Any updates will be included at the bottom of this article.MedicineCompanyValsartanMajor PharmaceuticalsValsartanSolco HealthcareValsartanTeva Pharmaceuticals Industries Ltd.Valsartan/Hydrochlorothiazide (HCTZ)Solco HealthcareValsartan/Hydrochlorothiazide (HCTZ)Teva Pharmaceuticals Industries Ltd.
Next steps you should take
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.
Contact your Tria Health pharmacist today for additional assistance with the recall process: 1.888.799.8742
Update [11/27/2018] – FDA alerts patients and health care professionals to Teva’s recall of valsartan products due to NDEA
Update [11/21/2018] – FDA alerts patients and health care professionals to Mylan’s recall of valsartan products due to NDEA
Update [10/24/2018] – FDA updates recalled valsartan-containing product information