Novo recalls insulin shots on mis-dosing fears
pharmafile | October 28, 2013 | News story | Manufacturing and Production | Novo Nordisk, flexpen, novomix, recall
Novo Nordisk is recalling around 3 million insulin products used to treat diabetes in Europe because of a possible manufacturing defect that could affect their potency.
The Danish drugmaker said the affected products were prefilled insulin injections sold under its NovoMix 30 (insulin aspart) FlexPen and Penfill brand names, and could deliver either too high or too low a dose of insulin, putting patients at risk of high or low blood sugar.
The European Medicines Agency (EMA) said it is ‘monitoring the situation closely’ and in the meantime is recommending that patients from the affected batches be switched to products from unaffected batches or, if unavailable, to alternative treatment.
The recall affects batches of NovoMix 30 FlexPen sold in Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, Luxemburg, Netherlands, Norway and Slovakia, said the company, which points out that other strengths of the product are unaffected.
Novo also noted that three batches of NovoMix 30 Penfill sold in the UK and Ireland were also being recalled, adding that it is possible these could have been shipped to other countries by parallel distributors. Both products supply rapid-acting and intermediate-acting insulin aspart in a 30/70 ratio.
“A quality control conducted by Novo Nordisk has shown that a small percentage (0.14%) of the products in these batches do not meet the specifications for insulin strength,” said the drugmaker.
Patients or their carers should be able to check the batch numbers printed on the pens against a listing on its website to see if their medicine is affected.
The EMA told patients to continue their treatment and to measure their blood glucose levels frequently in they have consulted their doctor, as insulin levels in the affected cartridges could vary between 50% and 150% of what is on the label.
The agency added that it will ensure “appropriate measures are being taken by the company, including immediate corrective actions as well as permanent technical solutions to prevent reoccurrence”.
All remaining units of the affected batches in Novo Nordisk control have reportedly been quarantined. NovoMix is one of the company’s most important insulin brands, accounting for around 15% of its total diabetes sales in the first half of this year.
Phil Taylor
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