Boots WebMD Partners in Health
Return To Boots

Diabetes health centre

This article is from the WebMD News Archive

Diabetes insulin pens and pen cartridges recall

WebMD UK Health News
Medically Reviewed by Dr Sheena Meredith
person taking blood test

28th October 2013 - People with diabetes who use insulin are being asked to check their insulin pens or cartridges.

The medicines regulator MHRA says a manufacturing fault has resulted in a precautionary recall across Europe of 33 specific batches of insulin pens and cartridges.

The products affected by the European recall are the Novo Nordisk NovoMix 30 Flexpen 100U/ml pre-filled pen and the NovoMix 30 Penfill 100U/ml cartridge.

A fault in filling of the cartridges could mean some batches contain too much or too little insulin.

The European medicines regulator EMA says that in affected cartridges, insulin levels may vary between 50% and 150% of the labelled amount and this could lead to hypoglycaemia or hyperglycaemia.

Around a million of these pens and cartridges were issued on prescription in England alone last year. The fault is said to affect a very small amount of the stock.

People with diabetes or their carers can check to see if they have pens or cartridges from the affected batches by looking to see if the following batch numbers are printed on the pen or cartridge: CS6D422, CS6C628, CS6C411, CP50912, CP50750, CP50639, CP51706, CP50940, CP50928, CP50903, CP50914, CP50640, CP51095, CP50904, CP50650, CP51098, CP50915, CP50412, CFG0003, CFG0002, CFG0001, CP50902, CP50749, CP50393, CP50950, CP51025, CP50751, CP50375, CP50420, CP51097, CP50641, CP51096 and CP50392.

What to do next

The MHRA says if insulin is not listed as part of the recall, it can still be taken as prescribed.

People with affected medicines should consult their GP or diabetes nurse to make arrangements for a new supply as soon possible.

In a statement, Gerald Heddell, the MHRA's director of inspection, enforcement and standards says: "In the meantime, it is important that patients do not stop their treatment. They are advised to continue taking their medicine but to measure their blood glucose levels frequently to ensure adequate blood sugar control and that they are in close contact with their carer, a friend or family member who can get medical help if necessary. Patients who experience symptoms of hypo- or hyperglycaemia should contact a healthcare professional immediately."

Simon O'Neill, Diabetes UK's director of health intelligence and professional liaison, adds: "The important thing is that anyone affected by this must keep taking their insulin but should get it replaced at the earliest opportunity. We recommend people test their blood glucose levels regularly and be aware that their glucose levels may potentially run higher or lower."

Reviewed on October 28, 2013

Diabetes newsletter

Tips for managing your diabetes.
Sign Up Now!

Popular slideshows & tools on BootsWebMD

man holding back
Myths & facts about back pain
hands grabbing knee
How to keep your joints healthy
bowl of soup
Small changes that lead to weight loss
cute baby
Simple tips to keep baby's skin healthy
cute dog
10 common allergy triggers
Do you know what causes hair loss?
woman exercising
Exercises for low back pain
sperm and egg
Facts to help you get pregnant
bucket with cleaning supplies in it
Cleaning for a healthy home
rash on skin
Soothe skin and prevent flare-ups
mother and child
Could your baby be allergic to milk?
pregnant woman eating healthy salad
Nutrition needs before pregnancy