Valsartan recall: Company recalls 80 lots (Details).
Aurobindo Pharma USA, Inc. has voluntarily recalled 80 lots of blood pressure medication, according to the FDA.
The medications include Amlodipine Valsartan Tablets USP, Valsartan HCTZ tablets, and USP and Valsartan Tablets USP, said the FDA. The tablets could have trace amounts of an unexpected impurity called N-nitrosodiethylamine, or NDEA.
The FDA said 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 (IARC) classification. The drug is intended to control high blood pressure and treat heart failure.
Patients taking the medication are encouraged to continue to take the medication because the health risk may be higher if discontinued without an alternative, the FDA said. See the list of affect products HERE.
The FDA said patients should contact their physician for advice on alternative treatment. Valsartan tablets were distributed nationwide.
Aurobindo Pharama USA, Inc. has not received any reports of adverse events related to this recall. Patients can contact 1-866-850-2876 to report a reaction.