Sandoz recalls losartan products that contain impurity

FDA
Sandoz has recalled one lot of losartan products made at its Lek Pharmaceuticals plant in Slovenia. (FiercePharma)

Months after world regulators first discovered impurities in the ingredient of a Chinese drugmaker, tainted drugs continue to show up in the U.S. supply. This time, it involves losartan blood pressure drugs from Sandoz.

The FDA and Sandoz announced on Friday 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 along with N-Nitrosodimethylamine (NDMA) are two probable human carcinogens that the FDA has discovered can be created during manufacturing under certain conditions.

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So far, the FDA has not received any reports that the trace amounts of the two impurities have resulted in adverse events but has pushed for the recalls as a matter of caution. The agency pointed out that Sandoz’s losartan drug products make up less than 1% of the total losartan drug products in the U.S. market.

The losartan API was manufactured by Zhejiang Huahai Pharmaceutical. A global recall was set off last summer  when the FDA and EU learned that the valsartan API made by Huahai contained the probable carcinogens. Since then, the agencies have been testing other “sartan” products including candesartan, irbesartan, losartan and olmesartan.