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Mylan Pharmaceuticals Expands Recall For Valsartan Drugs

  • November 21, 2018
  • KBA Attorneys
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Early in December, Mylan Pharmaceuticals announced the expansion of its voluntary recall of valsartan products. The recall took place because it was found that the products contained trace amounts of NDEA in the active pharmaceutical ingredient.

This recall affects all non-expired products that were distributed between March 2017 and November 2018. In the recall, there were 51 lots of valsartan tablets, 26 lots of amlodipine with valsartan tablets and 27 lots of valsartan with hydrochlorothiazide tablets. Mylan initially recalled only a few lots from each category. News of the recall was released just before the FDA announced that it improved its methods for detecting NDEA impurities in pharmaceutical substances.

Recalled Medications

Mylan released a specific list of its recalled valsartan-containing products. The expiration dates of the medications range between 2018 and 2020. However, most of the affected bottles have 2019 expiration dates. Mylan’s recall includes multiple dosages and quantities of the three affected products. Consumers should check medication packaging for a lot number. These are the recalled medications and their lot numbers.

Amlodipine and Valsartan:


  • 3063782
  • 3071352
  • 3061169
  • 3081499
  • 3080009
  • 3080010
  • 3079205

Valsartan and Hydrochlorothiazide:

  • 3084886
  • 3093804

Dangers of NDEA

NDEA is found in polluted air, in some foods, and in drinking water. NDEA is also included in some industrial processes. It is a naturally occurring substance. According to the International Agency for Research on Cancer, NDEA is classified as a probable carcinogen.

Uses for Valsartan

Valsartan is commonly used to reduce the risk of death after a heart attack. It is also used to treat heart failure and high blood pressure. When combined with hydrochlorothiazide or amlodipine, valsartan can lower blood pressure. The FDA says that any patients who take valsartan for these purposes should speak with a personal physician about an alternate medication option. However, it is essential to talk with a physician before stopping the valsartan-containing medication and returning it. According to the FDA, the risks associated with suddenly stopping the medication are more significant than the risks that exist from consuming trace amounts of NDEA. After consumers have talked to a doctor and have switched to another drug, they should call Stericycle at 1-888-406-9305 for instructions about returns and refunds on recalled Mylan products.

Attorneys Can Help

Some people have experienced adverse effects after using valsartan medications. Anyone who has experienced additional or worsening health problems after taking valsartan should see a physician and contact an attorney. Drug manufacturers are responsible for the issues that harmful medications cause. Consumers who develop serious problems after taking recalled valsartan products may be entitled to compensation for their drug injuries. There have been multiple drug recalls recently, and patients who have taken this drug should know their rights. The lawyers at KBA Attorneys have handled many cases for victims of dangerous pharmaceuticals and know how to help them collect money for damages. Victims may face long-term health issues that require costly medical care. To learn more and for a free case evaluation, contact KBA Attorneys.