WASHINGTON - Pharmaceutical company Aurobindo Pharma USA, Inc. has issued a voluntary recall of certain blood pressure tablets because they may contain trace amounts of a substance "classified as a probable human carcinogen."
The voluntary recall has been issued on 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP.
The company says that the voluntary level is due to the detection of trace amounts of an unexpected impurity found in the finished tablet.
Officials say the substance, N-nitrosodiethylamine (NDEA), occurs naturally in certain foods, drinking water, air pollution, and industrial processes.
It is however, classified as a probable human carcinogen, according to the International Agency for Research on Cancer (IARC) classification. Aurobindo Pharma USA, Inc. says it has not received any reports of adverse events related to this recall to date.
Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP are prescribed to control high blood pressure and for the treatment of heart failure.
Health officials say anyone who takes the impacted medications should continue taking their medication, with the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.
Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
The products subject to recall are listed below and packaged in bottles.
Officials say the product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.