Drug Safety Alerts

Aurobindo Pharma Amlodipine and Valsartan tablets, Valsartan and Hydrochlorothiazide Tablets and Valsartan Tablets Consumer-Level Recall

12/31/2018

On December 31, 2018, Aurobindo Pharma USA issued a consumer-level recall of amlodipine and valsartan tablets, valsartan and hydrochlorothiazide 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.

Amlodipine and valsartan tablets, valsartan and hydrochlorothiazide tablets and valsartan tablets are used for the treatment of high blood pressure, heart failure and to reduce cardiovascular mortality following myocardial infarction. 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, valsartan and hydrochlorothiazide tablets and valsartan tablets are used to treat serious medical conditions, the United States Food and Drug Administration (FDA) recommends that members should not stop their medicine until they receive replacement product or a different medicine to treat their condition.

A complete list of the affected products is provided at the end of this here:

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

For more information about this recall, health care providers may contact Aurobindo Pharma Inc. at 1-866-850-2876. You may also contact the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888-463-6332) or visit www.fda.gov.