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.
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.
The following batches are included in the irbesartan recall. All batches were manufactured by ScieGen and distributed to Westminister Pharmaceuticals.
|NDC#||Product Description||Lot#||Expiration Date|
|69367-119-01||Irbesartan 75mg Tablets, 30 count bottle||B160002A||Sep-19|
|69367-119-03||Irbesartan 75mg Tablets, 90 count bottle||B160002B||Sep-19|
|69367-120-01||Irbesartan 150mg Tablets, 30 count bottle||B161005A||Sep-19|
|69367-120-03||Irbesartan 150mg Tablets, 90 count bottle||B161005B||Sep-19|
|69367-121-01||Irbesartan 300mg Tablets, 30 count bottle||B162008A||Sep-19|
|69367-121-03||Irbesartan 300mg Tablets, 90 count bottle||B162008B||Sep-19|
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