Teva Pharmaceutical is recalling certain combinations of blood pressure drug valsartan in the United States following the detection of a probable cancer-causing impurity, the latest global recall of the medicine.
The Israeli drugmaker will recall all lots of amlodipine-valsartan and amlodipine-valsartan-hydrochlorothiazide combination tablets due to an impurity in an ingredient made by an India-based unit of Mylan, the U.S. Food and Drug Administration (FDA) said on Tuesday.
The European Union last week effectively banned sales of valsartan made by the Mylan India unit after some batches were found to contain the same impurity, N-nitrosodiethylamine.
Teva has not received any reports of adverse events signaling a potential link or exposure to valsartan, the health regulator said.
Patients are advised to continue taking their medication as the risk of harm may be higher if the treatment is stopped immediately without any comparable alternative treatment, the FDA said.