Aurobindo Pharma Limited has initiated the voluntary recall of 22 batches of the drug irbesartan, used to treat high blood pressure, from the US market.
The contaminant, N-nitrosodiethylamine (NDEA), is a substance that occurs naturally in certain foods, drinking water, air pollution and industrial processes and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC). said the FDA.
According to a statement from the US drug regulatory firm on its website, these 22 batches of the irbesartan drug were supplied by the municipal company Aurobindo to ScieGen Pharmaceuticals Inc., USA, for the manufacture of a complete irbesartan drug for the treatment of hypertension.
It can be used alone or in combination with other antihypertensive agents.
The final 75 mg, 150 mg and 300 mg irbesartan medicament manufactured by ScieGen Pharmaceuticals Inchave was named Westminster Pharmaceuticals and Golden State Medical Supply, Inc. (GSMS).
Aurobindo Pharma Limited has notified ScieGen Pharmaceuticals, Inc. of the recall and is initiating the return of all available irbesartan drug substances, "the FDA said.
The company also advised Sciegen Pharmaceuticals, Inc. to contact its distributors and retailers to return identified batches of the Irbesartan drug and finished Irbesartan tablets.
ScieGen Pharmaceuticals has also initiated the recall of the finished irbesartan drug from the market, the FDA said.
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