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Irbesartan Recall Lawsuit

In October 2018, the FDA recalled Irbesartan after finding the probable human carcinogen N-nitrosodiethylamine (NDEA) had contaminated the drug. The impurity may cause tumors in various organs, including the liver and kidney. This recall follows the Valsartan recall in July 2018. This contamination and recall of these “Sartan” drugs is the largest in FDA history.

Irbesartan Recall Lawsuit: Case Quick Facts

The Problem: Irbesartan and Cancer

Irbesartan is an angiotensin receptor blocker (ARB) prescribed to treat high blood pressure and kidney disease in patients with type 2 diabetes and high blood pressure. The brand name, Avapro, was approved by the FDA in 1997, while the generic, Irbesartan, was approved on March 30, 2012. A Valsartan recall in July 2018 prompted the FDA to investigate all ARBs for impurities. This led the FDA to find that the NDEA impurity had tainted Irbesartan.

The Injuries: Side Effects of Irbesartan

According to the Environmental Protection Agency, acute NDEA exposure may cause liver damage.

Long-term exposure can lead to:

  • Liver cancer
  • Kidney cancer
  • Stomach cancer
  • Intestinal/colon/colorectal cancer
  • Pancreatic cancer
  • Bladder cancer
The Defendant(s)

The recalled Irbesartan was manufactured by Aurobindo Pharma Limited. This company supplied Irbesartan to:

  • ScieGen Pharmaceuticals labeled as Westminster Pharmaceuticals
  • ScieGen Pharmaceuticals labeled as Golden State Medical Supply, Inc.

There are several other manufacturers of Irbesartan, including Teva Pharmaceuticals and Hetero Labs Limited. Not all Irbesartan is recalled, so if you are concerned that your medication was contaminated, you can compare your prescription with this list to determine if it was recalled.

GoldenbergLaw Can Help

If you or a loved one took Irbesartan and was diagnosed with cancer, contact us.

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FDA Irbesartan Recall – October 26, 2018

The FDA issued a recall for certain lots of Irbesartan. These lots were allegedly contaminated with NDEA.

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