Novartis’ Sandoz Recalls Losartan Product in the US Due to Impurity in API

Sandoz, the generics arm of Novartis, is voluntarily recalling in the US one lot of losartan potassium hydrochlorothiazide tablets (USP 100 mg/25 mg), an anti-hypertension drug, to the consumer level. The product is being recalled due to a trace amount of an impurity, N-nitrosodiethylamine (NDEA) found in the lorsartan active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical Co., a Linhai, China-based pharmaceutical company. 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 the International Agency for Research on Cancer, an intergovernmental agency forming part of the World Health Organization of the United Nations, according to information from the US Food and Drug Administration (FDA).

Sandoz’s losartan product is manufactured by Lek Pharmaceuticals, a Ljubljana, Slovenia-based Sandoz company. At the time of the recall, Sandoz reported it had not received any reports of adverse events related to this lot.

The recall of losartan is the third “sartan” product marketed in the US to be subject to investigation of possible carcinogenic impurities and subsequent recalls. Valsartan was the first, which triggered further investigation by the FDA and the European Medicines Agency (EMA). The FDA and EMA also investigated the “sartan” product irbesartan.

The FDA and EMA began their initial investigation into the “sartans” after the EMA learned that Zhejiang Huahai Pharmaceuticals (ZHP), a Linhai, China-based pharmaceutical company, had detected N-nitrosodimethylamine (NDMA) and NDEA, two probable human carcinogens, in several batches of its valsartan API. The FDA’s investigation began when a manufacturer of valsartan products detected NDMA in its API supplied from Zhejiang Huahai Pharmaceuticals, which followed with other companies recalling valsartan products. The EU’s detection of the two impurities led to an EU-wide review of all valsartan medicines marketed in the EU. The review was subsequently extended to other “sartan” medicines when very low levels of NDEA were found in losartan made by Hetero Labs, a Hyderabad, India-headquartered pharmaceutical company. In October 2018, the EMA updated that it was evaluating the APIs, candesartan, irbesartan, losartan, and olmesartan marketed in the EU in addition to its investigation into valsartan products. After low levels of NDEA were found in irbesartan, supplied to a US pharmaceutical company by Aurobindo Pharma, a Hyderabad, India-headquartered generics and API manufacturer, the FDA expanded its investigation to include both valsartan and irbesartan. Now, losartan is the second API outside of valsartan products to be found contaminated by NDEA for products marketed in the US.

Source: FDA

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