Aurobindo voluntarily recalls amlodipine/valsartan from US markets

Aurobindo Pharma recently announced a voluntary, consumerlevel recall of several lots of amlodipine/valsartan, valsartan/hydrochlorothiazide (HCTZ), and valsartan tablets due to the detection of trace amounts of an unexpected impurity, identified as n-nitrosodiethylamine (NDEA), found in the finished drug product. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer classification. Aurobindo Pharma has declared that it has not received any reports of adverse events as yet, related to this recall. The recalled products were distributed nationwide. Valsartan is used to control high blood pressure and for the treatment of heart failure. In combination with HCTZ or amlodipine, it is used for the treatment of high blood pressure. Patients taking amlodipine/valsartan combination tablets, valsartan/HCTZ combination tablets, or valsartan tablets have been advised to continue taking their medication and to contact their pharmacist or physician for advice on alternative treatment as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment. Patients have been advised to contact their healthcare provider if they have experienced any problems that may be related to using the recalled valsartan-containing product. Existing inventory of the recalled product are being quarantined.