FDA Expands Valsartan Recall

A key ingredient in many medications used to treat high blood pressure and heart failure, Valsartan, has been linked to an increased risk of cancer due to contamination from nitrosodimethylamine (NDMA). Several drugs containing the ingredient have already been recalled. On August 8, 2018, the U.S. Food and Drug Administration (FDA) announced it had expanded the recall list to include several other medications. According to the FDA website, “this recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products.”

A Serious Problem

The medications on the recall list containing contaminated Valsartan may have been polluted with a dangerous chemical known as n-nitrosodimethylamine (NDMA). The U.S. Environmental Protection Agency (EPA) has listed NDMA as a possible carcinogen. The chemical has been used in the past as an ingredient in liquid rocket fuel, CNN.com reported.

The following is a list of companies whose medications were tainted with NDMA contaminated Valsartan and have been added to the recall list:

• AvKare, A-S Medication Solutions LLC
• Bryant Ranch Prepack Inc.
• Camber Pharmaceuticals, Inc.
• H J Harkins Company
• Northwind Pharmaceuticals
• NuCare Pharmaceuticals Inc.
• Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC)
• Proficient Rx LP
• Remedy Repack
• Teva Pharmaceuticals (labeled as Major Pharmaceuticals)
• Teva Pharmaceuticals USA (labeled as Actavis)

The contaminated drugs were reportedly manufactured at a Chinese facility. The FDA, according to CNN, is working with the manufacturers in an effort to make sure future drugs containing Valsartan do not pose a health risk.

If you believe you have drugs containing tainted Valsartan, do not make any changes to your medicinal routine before talking to your doctor first.

Call Baron & Budd

Patients who took contaminated medications containing valsartan are filing lawsuits against the manufacturers of those drugs. They claim the companies failed to properly test their products and also failed to properly warn patients and doctors of the contamination. If you took a drug containing tainted valsartan, Baron & Budd may be able to help. Contact us online or call 866-723-1890 to learn more.