The blood pressure medication recalls just keep on coming! This time around, Aurobindo Pharma USA, Inc. has announced it is voluntarily recalling 80 lots of blood pressure medication after detecting trace amount of an unexpected impurity that could potentially cause cancer. The medication is used to control high blood pressure and for treatment of heart failure. The input detected, N-nitrosodiethylamine (NDEA), is a substance that occurs naturally in certain goods, air pollution, drinking water, and industrial presses.
It has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. The voluntary recall includes Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP. All recalled products have expiration dates between May 2019 to March 2021. Valsartan API is an active pharmaceutical ingredient made by Mylan India.
The Food and Drug Administration advises patients who are prescribed the medication to continue taking it, as the risk of harm to the patient health may be even higher if the treatment is stopped without any alternative medication. To date, Aurobindo Pharma USA, Inc, has not received a report of adverse event related to the recall.
Patients are urged to contact their doctor or pharmacist about an alternative treatment before returning their medication. If anyone has any medical questions regarding the recall, you can contact Aurobindo Pharma USA, Inc. by calling 1-866-850-2876 Option 2 or by emailing firstname.lastname@example.org. Aurobindo Pharma USA, Inc. is notifying it’s distributors and customers in writing and by phone to immediately discontinue distribution of the specific lots being recalled.
The products subject to recall can be found here. The product can be identified by checking the product name, batch or lot number on the bottle or by the manufacturer details.