COLUMBUS, Ohio (WSYX/WTTE) - The Food and Drug Administration says Aurobindo Pharma has recalled 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP due to trace amounts of an unexpected impurity found in the product.
The medication is used to control high blood pressure and for the treatment of heart failure.
FDA commissioner Scott Gottlieb, M.D. made a series of tweets about the recall Wednesday morning.
Per the FDA, the impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which 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 (IARC) classification.
The FDA says those who take the drug should continue to take it as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Those affected should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
The products were distributed nationwide to Aurobindo Pharma USA, Inc. wholesale, distributor, repackager and retail customers.
Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at: 1-866-850-2876 or firstname.lastname@example.org.