Direct healthcare professional communication on the recall of potentially impacted lots of EpiPen 0.3 mg solution for injection and EpiPen Junior 0.15 mg solution for injection (epinephrine) due to potential defects in auto-injectors
14.04.2017
Medical Intertrade d.o.o., the marketing authorisation holder for EpiPen 0.3 mg solution for injection and EpiPen Junior 0.15 mg solution for injection (epinephrine), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED), has informed healthcare professionals of the recall of potentially impacted lots of the specified medicines due to potential defects in auto-injectors.
Summary
- Two lots of EpiPen 0.3 mg solution for injection (lot 6FA292H with expiry date 09/2017 and lot 6FA292Y with expiry date 09/2017) and one lot of EpiPen Junior 0.15 mg solution for injection (lot 6ED117J with expiry date 08/2017) are recalled. The auto-injector devices of recalled lots may potentially contain a defective part that may result in the auto-injector failing to activate or requiring increased force to activate.
- Failure of the auto-injector to activate may result in patients not receiving the required dose of epinephrine (adrenaline), resulting in the worsening of symptoms of anaphylaxis or anaphylactic reactions, which could be life threatening.
- Healthcare professionals are advised to check if they have an EpiPen device from the lots which are subject to recall, and should instruct patients or their caregivers to do the same.
- Patients and/or their caregivers should be instructed to contact their pharmacy to arrange return of specified lots of EpiPen/EpiPen Jr. and obtain a replacement EpiPen/EpiPen Jr. medicine as soon as possible.
- Patients and/or their caregivers should also be instructed to keep EpiPen/EpiPen Jr. from the lots subject to recall, until a replacement EpiPen/EpiPen Jr. medicine is obtained.
- Patients and/or their caregivers should be advised that, in the event that a life-threatening allergic reaction (anaphylaxis) occurs before they can obtain a replacement EpiPen/EpiPen Jr. medicine, they should use EpiPen/EpiPen Jr. from the specified lots subject to recall, in accordance with the previous instructions for use, and then seek emergency medical attention.
Further information
The recall of specified lots of medicines is being conducted as a precautionary measure, as a result of the previous receipt of two international reports of device failing to activate due to a potential defect in a supplier component. Both reports refer to the lot 5FA665, which has not been distributed in the Republic of Croatia. There have been no confirmed reports of defects in device quality involving lots distributed in the Republic of Croatia.
The testing and analysis across the potentially impacted lots (6FA292H, 6FA292Y, 6ED117J) has not identified any units with a defect of components. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified a defect of components. However, the recall of the lots specified above is conducted out of precaution, as an additional safety measure.
Other lots of the specified medicines have been available on the Croatian market.
Here you may view the direct healthcare professional communication.
Healthcare professionals are reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
