Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP, and Valsartan Tablets USP Recalled

Pharmaceutical Technology Editors

Aurobindo Pharma USA, Inc. voluntarily recalled 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP, and Valsartan Tablets USP because of N-nitrosodiethylamine (NDEA) in the final drug product.

On Dec. 31, 2018, FDA announced that Aurobindo Pharma USA, Inc. had recalled 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, and Valsartan Tablets USP to the consumer level because trace amounts of N-nitrosodiethylamine (NDEA) were found in the finished drug product.  N-nitrosodiethylamine (NDEA), which occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, and Valsartan Tablets USP are used to treat high blood pressure and heart failure. Aurobindo Pharma USA, Inc. states that patients should continue to take their medication, however, as the risks “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.”

A complete list of recalled products and lot numbers can be found on FDA’s website. The company has not received any reports of adverse events as of the date of the recall. Adverse events may be reported to FDA through its MedWatch program.

Source: FDA