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Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, Amlodipine and Valsartan Tablets, and Valsartan and Hydrochlorothiazide Tablets


The drug manufacturer, Mylan Pharmaceuticals, issued a voluntary recall of the medication due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA). NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).

Valsartan is used for treatment of high blood pressure and heart failure. You should continue taking your medication, as the risk of harm to your health may be higher if the treatment is stopped immediately without any alternative treatment.

The US Food and Drug Administration (FDA) advises patients taking Valsartan should contact the doctor who prescribed the medication to discuss treatment, including alternative treatment options. You may find more information on these recalls by visiting the FDA’s website at: https://www.fda.gov/Safety/Recalls/default.htm.

Mylan Pharmaceuticals

https://www.fda.gov/Safety/Recalls/ucm626367.htm
  • Recall of 15 lots of valsartan containing products
  • Phone: 1-888-406-9305

Mylan is arranging for return of all recalled products. Wholesalers, retailers and consumers that are in possession of recalled product should contact Stericycle at 1-888-406-9305 for the return of the recalled product. Normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.

MedImpact Direct Mail® is dedicated to maintaining patient safety. We appreciate your business and will continue to strive to provide you with the best possible service. On every MedImpact Direct Mail® prescription label, there is a description of the drug name with the manufacturer indicated.