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Aurobindo Pharma Limited has initiated the voluntary recall of 22 batches of the US drug Irbesartan, used in the treatment of hypertension, due to the presence of an impurity, likely to cause cancer, announced the US Food and Drug Administration.
The impurity, N-nitrosodiethylamine (NDEA), is a substance naturally present in certain foods, drinking water, air pollution and industrial processes. It has been classified as a probable carcinogen for humans by the International Agency for Research on Cancer (IARC), the FDA said.
According to a notification from the US drug regulator on its website, these 22 batches of Irbesartan drug have been provided by Aurobindo, based in the city, to ScieGen Pharmaceuticals Inc., in the United States, for the manufacture of the finished drug Irbesartan intended to the treatment of hypertension.
It can be used alone or in combination with other antihypertensive agents.
The 75 mg, 150 mg and 300 mg Irbesartan finished drugs manufactured by ScieGen Pharmaceuticals Inc. have been labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc. (GSMS).
Aurobindo Pharma Limited has notified the recall to ScieGen Pharmaceuticals, Inc. and is arranging the return of any available drug substance, irbesartan, "the FDA said.
The company also advised Sciegen Pharmaceuticals, Inc. to contact its distributors and retailers for the return of identified batches of Irbesartan drug and finished Irbesartan tablets, he added.
ScieGen Pharmaceuticals also launched the recall of Irbesartan's finished product from the market, announced a separate notification from the FDA.
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