Important safety information Regarding EpiPen and EpiPen Jr auto injectors
Health Canada and Pfizer warn that some EpiPen and EpiPen Jr auto-injector devices may not slide out of their carrier tube easily, or at all.
Patients and Pharmacists are asked to immediately check their device(s) to confirm that it can be removed from the plastic carrier tube with ease.
Health Canada Safety Alert
EpiPen and EpiPen Jr are used to deliver an emergency treatment of adrenaline (epinephrine) to patients who are at risk or have a history of life-threatening allergic reactions (anaphylaxis).
Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. According to the company, a very small number of carrier tubes have a defect that partially blocks the opening of the tube and may prevent easy release of the auto-injector from the carrier. The issue is with the carrier tube, and not with the device itself or the drug that it delivers (epinephrine). The company has identified the root cause of this issue and put corrective measures in place.
Although the chance of this occurring is very rare, failure to administer epinephrine as soon as possible during an anaphylactic response could lead to patient disability or death. The number of EpiPen or EpiPen Jr auto-injectors with this issue is estimated to be two auto-injectors out of every one million. According to the company, there have been no reports of malfunctions related to this specific issue in Canada.
Products are not being recalled by Pfizer because the risk can be easily addressed by consumers and pharmacists checking devices—before an emergency situation arises—to make sure they slide easily out of their carrier tube. Should you have a device with this defect, please return it to your pharmacist for replacement.
Information for Pharmacists
When a patient returns a unit which does not easily slide out of the plastic carrier tube, please follow the process below:
Additional Information for Health Professionals and Patients
Before dispensing the EpiPen or EpiPen Jr Auto-Injectors expiring prior to and including September 2020, flip open the cap of the plastic carrier tube and carefully ensure that the auto-injector easily slides out of the plastic carrier tube. Detailed Directions.
If the EpiPen or EpiPen Jr Auto-Injector expires prior to and including September 2020, consumers should check their device now by flipping open the cap of the plastic carrier tube and carefully ensuring that the auto-injector easily slides out of the plastic carrier tube. Detailed Directions.