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Medication Safety Alerts

NovoPen Echo Voluntary Recall

7/6/2017

On July 6, 2017, Novo Nordisk issued a voluntary recall of insulin 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.The warning signs of high blood sugar (also known as hyperglycemia) typically appear gradually and might include flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting).

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

This recall affects the following batch numbers:

Batch Number (on the Carton)Batch Number (on the Device)
EVG1221-3EVG1221
EVG1226-2EVG1226
EVG1226-3EVG1226
FVG7149-1FVG7149
FVG7458-3FVG7458
FVG8134-2FVG8134
FVG8135-2 FVG8135

To see if you received affected product, please check the batch number. The batch number is printed on the NovoPen Echo towards the top of the device. If the product you have is not from one of these affected batch numbers, it is not affected by this recall. An example of the location of the batch number is provided here:

Novo Nordisk urges members who are using a NovoPen Echo from one of the affected batches to replace the cartridge holder because some could be damaged. If your NovoPen Echo is from one of the affected batches, please call FedEx Supply Chain toll-free at 1-855-419-8827, Monday through Friday, 8:00 am to 6:00 pm (ET) to receive a new cartridge holder. Novo Nordisk recommends that members who are using an affected pen may want to check their blood sugar level more often until receiving a new cartridge holder. Patients should contact their doctor if they believe they’re experiencing hyperglycemia.

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. 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 call your doctor.

CVS Caremark Response: If you are currently using NovoPen Echo, please call a Customer Care representative toll-free at 1-866-823-5184 for more information.

If you are currently using NovoPen Echo and have questions regarding this recall, please call your doctor or call Novo Nordisk Customer Care toll-free 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 call the United States Food and Drug Administration (FDA) toll-free at 1‑888‑INFO‑FDA (1‑888‑463-6332) or visit https://www.fda.gov.

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