European Medicines Agency initiates a recall of certain batches of the medicinal product NovoMix 30 FlexPen and Penfill
25.10.2013
Due to a quality defect, certain batches of the medicinal product NovoMix 30 FlexPen and Penfill are being recalled from the market in the EU Member States where affected batches have been distributed. The affected batches are not on the Croatian market and therefore the recall does not concern the Croatian market. The affected batches have never been placed on the market in Croatia, because the product for the Croatian market is not released at the manufacturing site that released the affected batches that are being recalled in the EU. Also, the recalled batches have never been placed on the market via interventional or parallel entry/import. The supply of the Croatian market with this medicine is going smoothly and there are other batches on the market not affected with this quality defect and therefore no reason for concern. In case that patient is in possession of the medicine NovoMix 30 and FlexPen or Penfill dispensed beyond the Croatian border, the following instructions should be followed:
Batches being recalled in the EU
The quality defect is a result in manufacturing problems due to which the affected batches may contain too high or too low amounts of insulin. Other strengths are not affected by this quality defect.
The batch numbers that are being recalled in the EU are indicated on the outer packaging an the pre-filled pen of the medicine NovoMix 30 FlexPen, or the glass cartridge of the NovoMix 30 Penfill.
The following batches of the medicine NovoMix 30 FlexPen are affected with this quality defect:
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 i CP50392.
The following batches of the medicine NovoMix 30 Penfillare affected with this quality defect :
CS6D422, CS6C628 and CS6C411.
The batches affected by the quality defect are have been distributed in the following Member States: Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, Ireland, Luxembourg, Netherlands, Norway, Slovakia and United Kingdom.
Instructions for patients who purchased the medicine NovoMix 30 FlexPen or Penfill out of the Croatian territory
Patients that have procured the medicine NovoMix 30 FlexPen or penfill out of the Croatian territory may not stop the their treatment without consultation with their doctor. Patients should check the batch number indicated on the pre-filled pen of the medicine NovoMix 30 FlexPen, or glass cartridge of the medicine NovoMix 30 Penfill. If the batch number does not correspond to some of the aforementioned numbers, no concern. If the batch number corresponds to some of the aforementioned numbers, the patient should follow the following instructions:
- consult with the doctor about an alternative treatment
- not stop the treatment without previously discussing it with the doctor
- as long as the appointment with the doctor has not taken place, patients are advised to measure the blood glucose level
- patients who feel symptoms of hypoglycaemia or hyperglycaemia should contact their doctor.
Instructions for doctors whose patients purchased the medicine NovoMix 30 FlexPen or Penfill out of the Croatian territory
Taking account that there are no batches on the Croatian market affected with this quality defect, doctors are advised to prescribe to patients the same medicine as before that it may be dispensed in any Croatian pharmacy.
More information is available on the web pages of the European Medicines Agency or here.
