Sandoz recalled of one lot of its antihypertensive combination drug Losartan HCT (losartan potassium and hydrochlorothiazide) for possible contamination.
The Novartis subsidiary announced the recall after finding trace amounts of N-nitrosodiethylamine (NDMA) a probable carcinogen traced back to Chinese API manufacturer Zhejiang Huahai. Sandoz said it has not received any reports of adverse events associated with the lot.
The affected product was distributed after October 8, according to the FDA. Sandoz called on distributors and retailers with affected products to stop distribution and quarantine any remaining stock.