Faulty diabetes pens in recall
Tuesday, 29 October 2013
People with diabetes or their carers are being asked to check their insulin pens or pen cartridges after a manufacturing fault has resulted in a precautionary recall across Europe of 33 specific batches of insulin pens and cartridges.
The manufacturing problem concerns a fault in the filling of the cartridges, which resulted in some batches of pens and cartridges containing too much or too little insulin.
In a medicines alert, The Medicines and Healthcare products Regulatory Agency (MHRA) said the affected products are the NovoMix 30 Flexpen 100U/ml pre-filled pen and the NovoMix 30 Penfill 100U/ml cartridge.
The MHRA said that last year alone, just over one million (1,063,599) prescriptions in England were dispensed for these insulin pens and cartridges. Information from the manufacturer shows that only around 0.14 per cent of the 3.3 million cartridges that are sold across Europe are likely to be affected by the manufacturing problem. Therefore, the safety risk to people with diabetes in the UK is likely to be limited to a small number of people. (more…)