An image of one of the lots of recalled blood pressure medicine from Aurobindo Pharma USA, Inc. (FDA)
The Food and Drug Administration is announcing a voluntary recall of a blood pressure and heart medicine which could contain a carcinogen.
Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP. The company said the recall comes due to the detection of trace amounts of N-nitrosodiethylamine (NDEA), a naturally-occurring substance that has been classified as a probable human carcinogen.
Aurobindo Pharma USA, Inc. says it has not received any reports of injuries or adverse affects related to this recall.
Patients who have been prescribed Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment, the company said.
Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
Lot and batch numbers can be found here, as well as images of affected products, which are packaged in bottles.
Aurobindo Pharma USA, Inc. is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled.