Drug Safety Alerts

NovoPen Echo Consumer-Level Recall

7/6/2017

On July 6, 2017, Novo Nordisk issued a consumer-level recall of cartridge holders used in a small number of NovoPen Echo^® devices. This recall was issued because the insulin cartridge holders may crack or break if exposed to certain chemicals, like certain cleaning agents. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar.

This recall affects the following batch numbers:

The batch number is printed on the NovoPen Echo towards the top of the device.

The affected batches were distributed between 8/1/2016 – 6/22/2017 to distributors, sales representatives and replacement programs for further distribution to pharmacies, healthcare providers and patients nationwide.

Novo Nordisk recommends that patients using an affected pen may want to check their blood sugar level more frequently until receiving a new cartridge holder. Patients should contact their health care provider if they believe they’re experiencing hyperglycemia. In order to receive a new cartridge holder, patients should call FedEx Supply Chain toll-free at 1-855-419-8827, Monday through Friday, 8:00 am to 6:00 pm (ET).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the United States Food and Drug Administration (FDA).

CVS Caremark Response: Because of this action, CVS Caremark is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using NovoPen Echo to contact their prescriber.

For more information about this recall, health care providers may contact Novo Nordisk Customer Care at 1-800-727-6500, Monday through Friday, 8:30 am to 6 pm (ET) or visit http://press.novonordisk-us.com.

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.