Novartis recalls NDEA-contaminated tablets in US

By Flora Southey

- Last updated on GMT

(Image: Getty/koksikoks)
(Image: Getty/koksikoks)

Related tags China Novartis Sandoz Fda

Sandoz is the latest Zhejiang Huahai Pharmaceutical customer to issue a nationwide recall after trace amounts of a probable carcinogen were found in the supplier’s API.

The voluntary recall relates to one lot of hypertension drug losartan potassium and hydrochlorothiazide tablets, USP 100mg/25mg.

According to the recall announcement​, N-nitrosodiethylamine (NDEA) – classified by the International Agency for Research on Cancer​ as a probable carcinogen – was detected in the product’s active pharmaceutical ingredient (API), losartan.

Sandoz, a subsidiary of Novartis, sourced the API from Chinese manufacturer Zhejiang Huahai Pharmaceutical Co. Ltd. The supplier has attracted much regulatory attention from the European Medicines Agency​, the US Food and Drug Administration​ (FDA), and the Chinese government​ this year, after both NDEA and another probable carcinogen, N-nitrosodimethylamine (NDMA), were detected in its APIs.

The announcement marks Sandoz’ second ‘sartan’ recall for the year. In June, the firm requested the return​ of specific batches of branded and generic valsartan products, and hydrochlorothiazide film-coated tablets in a number of countries outside of the US, having detected the NDMA impurity in Zhejiang Huahai-supplied ingredients.

Sandoz did not respond to a request for comment ahead of publication.

First non-sartan NDEA impurity

Last month, the FDA found trace amounts of NDEA in ScieGen Pharmaceutials’ hypertension drug irbesartan – the first NDEA impurity detected in a non-valsartan drug in the US.

ScieGen had sourced the contaminated API from supplier Aurobindo Pharma Limited.

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