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.