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AbledALERT Post Banner shows two insulin pen products from Novo Nordisk Pharmaceutical company with the headline: Novo Nordisk Recall: Insulin pen products recalled in 12 European Union Countries.

Certain batches of NovoMix®30FlexPen® and NovoMix®30Penfill® recalled

 

Pharmaceutical company Novo Nordisk is warning diabetics in Europe that certain insulin pens may dispense the wrong dosage because of a manufacturing defect at a plant in China.  As a result, the company has issued a recall of certain lots of NovoMix®30FlexPen® and NovoMix®30Penfill® cartridges.

 

The insulin pens are used by diabetic patients to regulate their blood sugar levels. Use of the affected pens can lead to excessively high or low blood glucose in patients. A spokeswoman for the pharmaceutical company estimates there are about 150 pens on the market with the wrong dosage.

 

To protect patient safety Novo Nordisk is recalling all products in the affected batches from wholesalers, pharmacies and patients in the following E.U. countries: Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, Luxemburg, Netherlands, Norway and Slovakia. In Ireland and the UK, three batches of NovoMix®30 Penfill® are being recalled. Other countries in the EU might have received the affected batches through parallel distribution.

 

Country Product name Batch number Expiry date
Austria NOVOMIX 30 FLEXPEN 5X3 ML CP50912 10/2014
Austria NOVOMIX 30 FLEXPEN 5X3 ML CP50750 07/2014
Austria NOVOMIX 30 FLEXPEN 5X3 ML CP50639 07/2014
Belgium NOVOMIX 30 FLEXPEN 5X3 ML CP51706 01/2015
Belgium NOVOMIX 30 FLEXPEN 5X3 ML CP50940 10/2014
Belgium NOVOMIX 30 FLEXPEN 5X3 ML CP50928 10/2014
Belgium NOVOMIX 30 FLEXPEN 5X3 ML CP50903 10/2014
Belgium NOVOMIX 30 FLEXPEN 5X3 ML CP50914 10/2014
Belgium NOVOMIX 30 FLEXPEN 5X3 ML CP50640 07/2014
Czech Republic NOVOMIX 30 FLEXPEN 5X3 ML CP51095 10/2014
Czech Republic NOVOMIX 30 FLEXPEN 5X3 ML CP50904 10/2014
Czech Republic NOVOMIX 30 FLEXPEN 5X3 ML CP50650 07/2014
Denmark NOVOMIX 30 FLEXPEN 5X3 ML CP51098 10/2014
Denmark NOVOMIX 30 FLEXPEN 5X3 ML CP50915 10/2014
Denmark NOVOMIX 30 FLEXPEN 5X3 ML CP50412 07/2014
France NOVOMIX 30 FLEXPEN 5X3 ML CFG0003 09/2014
France NOVOMIX 30 FLEXPEN 5X3 ML CFG0002 09/2014
France NOVOMIX 30 FLEXPEN 5X3 ML CFG0001 09/2014
Germany NOVOMIX 30 FLEXPEN 10X3 ML CP50902 10/2014
Germany NOVOMIX 30 FLEXPEN 5X3 ML KP CP50749 07/2014
Germany NOVOMIX 30 FLEXPEN 5X3 ML CP50393 07/2014
Iceland NOVOMIX 30 FLEXPEN 5X3 ML CP51098 10/2014
Ireland NOVOMIX 30 PENFILL 100 5X3 ML CS6D422 10/2014
Ireland NOVOMIX 30 PENFILL 100 5X3 ML CS6C628 09/2014
Ireland NOVOMIX 30 PENFILL 100 5X3 ML CS6C411 08/2014
Luxemburg NOVOMIX 30 FLEXPEN 5X3 ML CP51706 01/2015
Luxemburg NOVOMIX 30 FLEXPEN 5X3 ML CP50940 10/2014
Luxemburg NOVOMIX 30 FLEXPEN 5X3 ML CP50928 10/2014
Luxemburg NOVOMIX 30 FLEXPEN 5X3 ML CP50903 10/2014
Luxemburg NOVOMIX 30 FLEXPEN 5X3 ML CP50914 10/2014
Luxemburg NOVOMIX 30 FLEXPEN 5X3 ML CP50640 07/2014
Netherlands NOVOMIX 30 FLEXPEN 5X3 ML CP50950 10/2014
Netherlands NOVOMIX 30 FLEXPEN 5X3 ML CP51025 10/2014
Netherlands NOVOMIX 30 FLEXPEN 5X3 ML CP50751 07/2014
Netherlands NOVOMIX 30 FLEXPEN 5X3 ML CP50375 07/2014
Netherlands NOVOMIX 30 FLEXPEN 5X3 ML CP50420 07/2014
Norway NOVOMIX 30 FLEXPEN 5X3 ML CP51097 10/2014
Norway NOVOMIX 30 FLEXPEN 5X3 ML CP50641 07/2014
Slovakia NOVOMIX 30 FLEXPEN 10X3 ML CP51096 10/2014
Slovakia NOVOMIX 30 FLEXPEN 10X3 ML CP50392 07/2014
UK NOVOMIX 30 PENFILL 100 5X3 ML CS6D422 10/2014
UK NOVOMIX 30 PENFILL 100 5X3 ML CS6C628 09/2014
UK NOVOMIX 30 PENFILL 100 5X3 ML CS6C411 08/2014

 

From the company website:

 

Patients or carers may themselves check the batch number printed on the pen to see if their medicine is affected. For patients using a NovoMix®30 FlexPen® product with a batch number not mentioned above there is no concern and they can continue their treatment as usual. The same applies to patients using other Novo Nordisk products.

 

Patients using a NovoMix®30 FlexPen® with one of the above-mentioned batch numbers should take special precautions as described below.

 

Risk of high or low blood sugar

 

Around 0.14% of the NovoMix®30 FlexPen® with one of the mentioned batch numbers might have either a too high or a too low insulin strength. For patients using a product with one of these batch numbers this means there is a risk that the number of insulin units received in an injection will either be lower or higher than the dose selected. This could lead to high blood sugar (hyperglycaemia) or low blood sugar (hypoglycaemia).

 

Advice to patients using NovoMix®30 FlexPen® with one of the mentioned batch numbers:

 

  • Do not stop treatment without consulting your doctor
  • Measure your blood sugar level frequently to ensure it is well controlled
  • In the event that you experience symptoms of low or high blood sugar involving this product, contact your doctor for advice
  • Make an appointment with your doctor or nurse to get a replacement product as soon as it is feasible
  • Return NovoMix®30 products with the above mentioned batch numbers to your pharmacy when picking up the replacement product
  • Report any adverse drug reactions to Novo Nordisk’s customer service in the country you reside. Contact information can be found on the website of Novo Nordisk’s affiliate in the country. Links to these websites are available on novonordisk.com

 

Novo Nordisk is committed to delivering high-quality products and sincerely apologises for this unfortunate situation and the concerns and inconvenience it may cause patients and health care professionals. We are working closely with national health authorities to ensure patient safety and minimise the disruption this recall causes.

 

Symptoms of high and low blood sugar

 

The symptoms of high blood sugar (hyperglycaemia) are increased amount and frequency of urination, excessive thirst, nausea, tiredness or vomiting. The symptoms of low blood sugar (hypoglycaemia) are drowsiness, palpitations, sweating, pallor, numbness, headaches, irritability, fatigue, slurred speech, ”pins and needles” sensation on your skin or coma.

 

About NovoMix®30 FlexPen®

 

NovoMix®30 (Biphasic insulin aspart 30) is a biphasic suspension of the insulin analogue, insulin aspart. The suspension contains rapid-acting and intermediate-acting insulin aspart in the ratio 30/70. NovoMix®30 is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above. NovoMix®30 FlexPen® is prefilled injection device.

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AbledALERT Infobox headline reads: Insulin Pen Recall: Novo Nordisk: NovoMix 30FlexPen and NovoMix 30 Penfill.

 

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