Drug Safety Alerts

Aurobindo Amlodipine and Valsartan tablets and Valsartan tablets - Consumer-Level Recall

02/28/2019

On February 28, 2019, Aurobindo Pharma USA issued a consumer-level recall of amlodipine and valsartan tablets and valsartan tablets. This recall was issued 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.

A complete list of the affected products and lot numbers is provided here:

Amlodipine and valsartan tablets and valsartan tablets are used for the treatment of high blood pressure and for the treatment of heart failure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

Because amlodipine and valsartan tablets and valsartan tabletsare used to treat serious medical conditions, the United States Food and Drug Administration (FDA) recommends that patients should not stop their medicine until they receive replacement product or a different medicine to treat their condition.

CVS Caremark Response: Because of this action, CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking amlodipine and valsartan tablets and valsartan tablets to contact their prescriber.

For more information, please contact Aurobindo Pharma Inc.1-866-850-2876 or visit www.aurobindousa.com. You may also call the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at www.fda.gov.