January 10, 2019 — Aurobindo Pharma USA Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. 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. To date, Aurobindo Pharma USA Inc. has not received any reports of adverse events related to this recall.
The affected medications are indicated to control high blood pressure and for the treatment of heart failure. Patients who were prescribed Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP should continue taking their medication, as 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 on the U.S. Food and Drug Administration (FDA) website here. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
The affected medications were distributed nationwide to Aurobindo Pharma USA Inc. wholesale, distributor, repackager and retail customers. Aurobindo Pharma USA Inc. is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. The company is arranging for return of all recalled products to Inmar/CLS Medturn. Instructions for returning recalled products are given in the recall letter.
Mylan Pharmaceuticals announced a recall of all lots of its products containing Valsartan in December. The affected products in that recall were manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Ltd., and distributed in the U.S. between March 2017 and November 2018.
For more information: www.fda.gov