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TEHRAN, November 04 -A pharmaceutical company is recalling a blood pressure medication because it could contain an impurity scientists believe could cause cancer.
TEHRAN, Young Journalists Club (YJC) -A pharmaceutical company is recalling a blood pressure medication because it could contain an impurity scientists believe could cause cancer.
ScieGen Pharmaceuticals announced the recall this week for Irbesartan tablets in 75 mg, 150 mg and 300 mg doses. The company said trace amounts of N-Nitrosodiethylamine, or NDEA, was discovered in the active pharmaceutical ingredient.
Some Irbesartan tablets made by ScieGen labeled under Westminster Pharmaceuticals and Golden State Medical Supply are impacted by the voluntary recall.
"This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a 'probable human carcinogen as per International Agency for Research on Cancer,'" the company stated.
"To date, ScieGen Pharmaceuticals Inc. has not received any reports of adverse events related to this product."
Irbesartan treats hypertension and can be used alone or in combination with other drugs.
"Westminster is notifying its direct accounts by email and by phone to immediately discontinue distribution of the product being recalled and to notify their wholesale and retail accounts of this product recall and make arrangements for impacted product to be returned to Westminster," ScieGen said in a statement.
"Patients should return the affected medication to their pharmacy. Pharmacies should return their affected stock to their wholesaler."
Last week, Aurobindo Pharma Limited announced a voluntarily recalling 22 batches of Irbesartan due to the presence of NDEA, the U.S. Food and Drug Administration said. Those batches were supplied to ScieGen Pharmaceuticals for manufacturing.
Source: UPI
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