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FDA Recalls Popular Blood Pressure Drug for Cancer Risk


The U.S. Food and Drug Administration (FDA) has issued a recall for the popular blood pressure drug irbesartan (Avapro) after determining the medication may be contaminated with a known cancer-causing agent.

About the Ibesartan Recall

According to Fortune, FDA testing of the drug found pills contained the carcinogen N-nitrosodiethylamine (NDEA) which is believed to be a byproduct of the manufacturing process.

According to the U.S. Environmental Protection Agency, N-nitrosodimethylamine is human carcinogen, meaning it causes cancer in humans. The chemical can be found in water supplies and food in very small amounts.

In June, the FDA also recalled valsartan for NDA contamination. Irbesartan is the first non-valsartan pharmaceutical found by the FDA to contain the NDEA impurity.

Products Covered by the Irbesartan Recall

The following batches are included in the irbesartan recall. All batches were manufactured by ScieGen and distributed to Westminister Pharmaceuticals.

NDC#Product DescriptionLot#Expiration Date
69367-119-01Irbesartan 75mg Tablets, 30 count bottleB160002ASep-19
69367-119-03Irbesartan 75mg Tablets, 90 count bottleB160002BSep-19
69367-120-01Irbesartan 150mg Tablets, 30 count bottleB161005ASep-19
C161002AFeb-20
69367-120-03Irbesartan 150mg Tablets, 90 count bottleB161005BSep-19
C161002BFeb-20
69367-121-01Irbesartan 300mg Tablets, 30 count bottleB162008ASep-19
C162002AFeb-20
69367-121-03Irbesartan 300mg Tablets, 90 count bottleB162008BSep-19
C162002BFeb-20

Contact an Experienced Drug Recall Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

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