UPDATE (for Canada):
April 1 2017 – Pfizer Canada, in consultation with Health Canada, is voluntarily recalling one lot of EpiPen auto-injector and one lot of EpiPen Jr. auto-injector as the recalled devices may 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 adrenaline (epinephrine), resulting in the worsening of symptoms of anaphylaxis or anaphylactic reactions, which could be life threatening.
There have been no confirmed reports of device failures involving lots distributed in Canada.
Canadian products affected (US products listed below):
- EpiPen (0.3 mg epinephrine) auto-injector lot 5GU763, expiry date May 2017, 67844 units distributed in Canada
- EpiPen Jr (0.15 mg epinephrine) auto-injector lot 5GR765, expiry date March 2017, 39503 units distributed in Canada
Patients and caregivers should check whether they have the affected device and contact their pharmacy to arrange return and obtain a free replacement as soon as possible.
March 22, 2017 – Mylan pharmaceutical has issued a major recall on thousands of EpiPens, which are emergency medications for adverse allergic reactions.
The recall was issued Monday, March 20 2017 on its selection of EpiPen 300 microgram Injection Syringe AutoInjectors after the company discovered that the affected devices could “contain a defective part” that resulted in the pens failing to activate. The failure of the autoinjector to activate may result in patients not receiving the required dose of adrenaline resulting I worsening symptoms of anaphylaxis or anaphylactic reactions,” the statement read.
EpiPens that fail to activate or that require excessive force to activate pose a very serious, life-threatening issue to those suffering from serious allergies. Serious food allergies can lead to anaphylaxis — a severe, potentially life-threatening allergic reaction that can occur within seconds or minutes of exposure to something you’re allergic to. The first line of treatment prescribed for an attack is epinephrine.Two reports worldwide were confirmed at the time of the announcement.
According to a release from Alphapharm, the recall extended to 80,000 pens worldwide.
The following batch numbers were confirmed as follows: 5FA665, 5FA6651, 5FA6652, 5FA6653, all listed with an expiration date of April /17.
Alphapharm recommended that anyone with an EpiPen, check the yellow box and/or label on the EpiPen itself to confirm the batch number and expiration date. If boxes feature the “Apr 17” expiration date AND/OR one of the aforementioned batch numbers, the company recommended that consumers replace the pens immediately, by returning them to a pharmacist.
Pharmacists are required to replace all potentially defective EpiPens with new ones or an EpiPen 300pug – for free.