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Some batches of blood pressure medications have been recalled because they may contain an impurity suspected to cause cancer, the US Food and Drug Administration said Tuesday.
The voluntary recall has implications for some Irbesartan tablets manufactured by ScieGen Pharmaceuticals and bearing the names Westminster Pharmaceuticals and Golden State Medical Supply, Inc. (GSMS).
The FDA has indicated that the affected products were recalled due to the presence of an impurity: N-nitrosodiethylamine (NDEA). According to the FDA, the International Agency for Research on Cancer has listed the substance among the potentially carcinogenic substances for humans.
The FDA has published a complete list of lots of drugs made, sold in 75 mg, 150 mg and 300 mg doses.
For patients whose medications are part of the recalled batches, the FDA recommends contacting a pharmacist or doctor for alternative treatment. Patients should continue to take their medications until another treatment can be arranged, as an immediate arrest could be more harmful, according to the FDA.
October 26th: This week's recalls: millions of pounds of ready-to-eat foods, as well as Ford Focus and BMW cars
The NDA "occurs naturally in certain foods, in drinking water, in air pollution and in industrial processes," says the FDA.
Irbesartan is prescribed to treat high blood pressure and can be used to treat kidney failure in some patients, according to a publication of the US National Library of Medicine.
As of Tuesday's publication date, ScieGen Pharmaceuticals was unaware of any adverse events related to the recall, the FDA announced.
On October 26, the FDA announced that Aurobindo Pharma Limited had recalled 22 batches of Irbesartan, which had been sent to ScieGen Pharmaceuticals Inc., USA, for processing into Irbesartan finished drug.
The recall of Irbesartan follows a similar reminder in August for valsartan, a medicine for the heart.
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