By Alex Keown
The FDA said Hauppauge, N.Y.-based ScieGen Pharmaceuticals is voluntarily recalling listed lots of Irbesartan Tablets, in doses of 75 mg, 150 mg, and 300 mg due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The tablets have been manufactured by Aurobindo Pharma Limited, the FDA said. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes. However, NDEA has been classified as a probable human carcinogen as per International Agency for Research on Cancer.
In an announcement on its website, ScieGen said as of Oct. 29, it had not received reports of adverse events related to the product.
The products that are being recalled have the names Westminster Pharmaceuticals and Golden State Medical Supply, Inc. on the label, the FDA said.
Irbesartan is an angiotensin II receptor blocker (ARB) that works by blocking a substance in the body known as angiotensin that causes blood vessels to tighten. As a result of its mechanism, irbesartan relaxes blood vessels, which lowers blood pressure and increases the supply of blood and oxygen to the heart.
This is the second cardiovascular drug in the past several months to be recalled due to contamination. In July the FDA issued a voluntary recall of drugs that contained the active ingredient valsartan, which is also used to treat high blood pressure and heart failure. In that recall, an impurity known as N-nitrosodimethylamine (NDMA), another carcinogen, was found in the products. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured, the FDA said in July.
Like Irbesartan, valsartan is also an ARB. CNN reported that the FDA is conducting tests on ARBs for impurities such as the carcinogens. The agency had to design a special test after it learned that some ingredients imported from one company in China, Zhejiang Huahai Pharmaceuticals, were tainted, CNN said. Zhejiang Huahai Pharmaceuticals has been placed on an import alert list, according to the report.
For Irbesartan, the FDA said Westminster has notified its direct customers by telephone and mail to immediately discontinue distribution of the recalled product. Products affected by the recall can be best identified by patients as being white, oval-shaped tablets debossed with SG 160; SG 161; or SG 162, the FDA said. The Irbesartan tablets subject to recall are packed in 30-count and 90-count bottles.