Drug Safety Alerts

Entresto® Patient-Level Recall

7/6/18

On July 6, 2018, Novartis issued a patient-level recall of Entresto^® Hospital Unit Dose (HUD) tablets. This action is not a result of any quality or safety concerns with the medications for their intended use. The blister cards in which the affected products are packaged are not child-resistant, posing a risk of harm if the tablets are swallowed by children. As a result, Novartis is voluntarily recalling the products in the United States. Novartis is asking wholesalers and pharmacies to return any affected product in stock. To avoid potential interruption of patients’ current supply of medication and dosing regimen, Novartis is offering patient child-resistant pouches in which to store the affected drugs as an interim measure to address this issue. Patients may continue to use the products as directed.

A complete list of the affected products is provided at www.pharma.us.novartis.com/recall-zofran-and-entresto-packages.

CVS Caremark Response: Entresto Hospital Unit Dose (HUD) tablets are not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact 1-888-NOW-NOVA (1‑888‑669-6682), Monday through Friday 8:00 am to 8:00 pm (ET) and 9:00 am to 6:00 pm (ET) Saturday and Sunday or visit www.pharma.us.novartis.com/recall-zofran-and-entresto-packages.

You may also call the United States Food and Drug Administration at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov/.