Sandoz recalls losartan with NDEA impurity; FDA publishes Q&As on sartan saga

By PharmaCompass

2018-11-22

Impressions: 125 Article

After months of discovering probable cancer-causing impurities in sartan APIs manufactured by China’s Zhejiang Huahai Pharmaceutical, tainted drugs continue to show up in the US. The latest company to spring up in the saga is Sandoz.

Last week, the US Food and Drug Administration (FDA) and Sandoz announced that the Novartis unit is recalling one lot of losartan that was manufactured by its Lek Pharmaceuticals unit in Ljubljana, Slovenia, because its contains N-nitrosodiethylamine (NDEA), a suspected carcinogen. NDEA and N-Nitrosodimethylamine (NDMA) are two probable human carcinogens.

The Huahai episode has led to recalls across countries of sartan APIs. Regulatory agencies across the world continue to test other “sartan” products including candesartan, irbesartan, losartan and Olmesartan for cancer-causing impurities.

Meanwhile, the FDA has posted Q&As on impurities found in certain generic angiotensin II receptor blocker (ARB) products. ARBs include ‘sartan’ drugs, such as candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, and valsartan. ARBs are commonly used to treat high blood pressure and heart failure.

“The FDA has identified factors in manufacturing processes that may contribute to the formation of NDMA and NDEA. As part of our investigation, we are working to ensure that other manufacturing conditions do not contribute to NDMA, NDEA, or related impurities in finished drug products,” the agency said.

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