Drug Safety Alerts

American Health Packaging Valsartan 160 mg Tablets Consumer-Level Recall

03/07/2019

On March 7, 2019, American Health Packaging issued a consumer-recall of valsartan 160 mg tablets manufactured by Aurobindo Pharma that were repackaged and distributed by American Health Packaging. 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. This recall is being initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which included the affected lot that was repackaged by American Health Packaging.

This recall affects lot number 179791 exp. 03/31/20.

Valsartan tablets are indicated to control high blood pressure and for the treatment of heart failure. Patients who are prescribed valsartan tablets 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.

CVS Caremark Response:

Please note: The repackaged product distributed by American Health Packaging is not carried by the CVS Caremark mail Service Pharmacies.

For more information about this recall, please contact American Health Packaging at 1-800-707-4621. You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.