Novomix 30 Flexpen Recall Issued in Europe for Insulin Pens

More than 3 million insulin products sold by Novo Nordisk are being recalled in 13 different European countries due to a production problem discovered that may impact the amount of insulin diabetic patients are exposed to.

A NovoMix 30 FlexPen recall was issued by the Danish drug maker on October 25, impacting certain batches of the FlexPen and Penfill cartridge products. The insulin pens may not meet proper strengths, containing either too low or too high amounts.

There are currently no reports of injuries associated with use of the insulin pens, which were shipped in March to consumers in Europe for use by adults and kids over the age of 10 with diabetes.

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The production problems reportedly only affected about 0.14 percent of the products, but Novo Nordisk is opting to recall many of the products since the problem can cause severe side effects in diabetic users.

The batches with problems can contain a level of insulin that can vary between 50 to 150 percent of the labelled dose. A dosage which varies that significantly can result in severe side effects for diabetic users.

Incorrect insulin strength can lead to low or high blood sugar levels. Symptoms of low blood sugar can include drowsiness, palpitations, numbness, headaches, fatigue, slurred speech and coma. Symptoms of high blood sugar may include increased amount and frequency of urination, excessive thirst, nausea, tiredness or vomiting.

None of the recalled products were sold in the United States, with the products only shipped to Austria, Belgium, Czech republic, Denmark, France, Germany, Iceland, Ireland, Luxemburg, Netherlands, Norway, the UK and Slovakia. Other European countries may have been affected through parallel distribution.

Patients in Europe have been advised to check their insulin pens to determine if their products are affected by the recall. The batch number is printed on the side of the pen. Affected products should be returned to the pharmacy when picking up a replacement product.

Novo Nordisk recommends continuing treatment with the product until consulting your doctor or receiving a replacement product. Blood sugar levels should be checked frequently to ensure insulin levels are under control.

Patients have been advised to contact their doctor immediately if they experience any symptoms of high or low blood sugar. If your product is not from the affected batch, no action is necessary.


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