Important safety information for people with diabetes using NovoPen Echo or NovoPen 5

Starting date:
July 25, 2017
Type of communication:
Advisory
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public
Identification number:
RA-64056

Issue

Health Canada is advising Canadians that Novo Nordisk A/S has updated a voluntary recall of insulin cartridge holders used in certain lots of its NovoPen Echo and NovoPen 5 insulin pens. The company detected that the cartridge holders may crack or break if exposed to certain chemicals, such as some cleaning agents.

Affected Products

NovoPen Echo:
Device Lot Number Package Lot Number
DUG2373 DUG2373-5
DVG1368 DVG1368-B
EVG2915 EVG2915-7
EVG3010 EVG3010-2
EVG4252 EVG4252-6
EVG5699 EVG5699-6
EVG5946 EVG5946-7
EVG5963 EVG5963-1
FVG7337 FVG7337-2
FVG7561 FVG7561-1
FVG8131 FVG8131-5
FVG8132 FVG8132-6
FVG8212 FVG8212-1
FVG8414 FVG8414-9
FVG8994 FVG8994-1
FVG8997 FVG8997-1
NovoPen 5:
Device Lot Number Package Lot Number
EVG5564 EVG6240
EVG3337 EVG6241
EVG5564 FVG6867
EVG0915 FVG6868
FVG7336 FVG7469
FVG7377 FVG7568

What you should do

  • Do not stop treatment without consulting your health care professional.
  • Contact Novo Nordisk Customer Service in order to receive an unaffected cartridge holder for your NovoPen Echo or NovoPen 5 product, or if you have any questions about this recall. You can contact the company by calling 1-800-465-4334, emailing NNCI_CustomerCare@novonordisk.com, or by completing the form on the company's website.
  • In the event that you experience symptoms of high blood sugar or any health concerns involving this product, contact your healthcare professional for advice. Measure your blood sugar levels as instructed by your healthcare professional, and more frequently if symptoms of high or low blood sugar develop unexpectedly.
  • Report complaints about health products to Health Canada by calling toll-free at 1-800-267-9675, or complete an online complaint form.

Background

Novo Nordisk A/S has advised that using a device with a cracked or broken cartridge holder can result in a smaller dose of insulin than expected, which may lead to hyperglycemia (high blood sugar). According to Novo Nordisk A/S, the risk of experiencing high blood sugar with the use of a device with an affected cartridge holder is evaluated to be less than 0.1 per cent. This means that less than one in 1,000 patients with an affected cartridge holder will experience high blood sugar.

Warning symptoms of high blood sugar include: flushed, dry skin, sleepiness or tiredness, dry mouth, breath that smells fruity or like acetone (nail polish remover), frequent urination, feeling thirsty, loss of appetite, nausea, and vomiting. It is possible that high blood sugar may only be seen by measuring blood sugar levels, and may not display any physical signs.

Novo Nordisk A/S has confirmed that the cartridge holder issue does not affect NovoPen Echo or NovoPen 5 devices with a lot number that is not mentioned above.

Novopen 5 and Novopen Echo (2017-07-05)

2017-07-05 | Health products

Recall

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

Images

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