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Medication Safety Alerts

Entresto® Voluntary Recall

July 6, 2018

On July 6, 2018, Novartis issued a voluntary recall of Entresto® Hospital Unit Dose (HUD) tablets. This recall was issued because the packaging for these products are not child-resistant which could pose a risk of harm if the tablets are swallowed by children.

Please note: There are no quality or safety concerns with these products. Please do not stop taking your medicine without talking to your doctor. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please contact your doctor.

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

To see if you have affected product, please check the lot number. The lot number is located on the manufacturer’s packaging. If you have product affected by this recall, Novartis will provide you with a child-resistant pouch to secure your medicine. Please call Novartis toll-free at 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 to order your child-resistant pouch. Please provide the following information:

  • Patient name, address and phone number.
  • Number of Entresto blistercards in your possession.

Novartis will send you a child-resistant pouch to store your medicine. Immediately secure and store your medicine out of the sight and reach of children until the child-resistant pouch is received. If you are currently taking Entresto Hospital Unit Dose (HUD) tablets and have not discussed this recall with your doctor, please call a Customer Care representative toll-free at 1-866-823-5184 for more information.

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

If you are currently taking Entresto Hospital Unit Dose (HUD) tabletsand have questions regarding this recall, please call your doctor or call Novartis toll-free at 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 U.S. Food and Drug Administration (FDA) consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.

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