Novartis said its Sandoz division is recalling one lot of losartan tablets after finding traces of a probable carcinogen in the blood pressure drug.
The recall is due to a small amount of the impurity, N-nitrosodiethylamine, found in the API Losartan. The drug is made by China’s Zhejiang Huahai Pharmaceutical, which was placed under high supervision last month by the EMA after a probable carcinogen was found in its blood pressure drug, valsartan.
No adverse events have been reported but Novartis is notifying its distributors by letter via overnight mail and patients by public notification.
Read the press release