Epipen inc Jnr

Notice Date

Saturday 01 April 2017

Product Description

EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) Auto-Injectors

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

 

Defect

There is a potential that these devices may contain a defective part that may result in the device failing to activate or requiring increased force to activate.

Hazards

The failure of the auto-injector to activate may result in patients not receiving the required dose of adrenaline, causing the worsening of symptoms of anaphylaxis or anaphylactic reactions, which could be life threatening.

What To Do

Patients and caregivers should check whether they have the affected device.
Contact your pharmacy to arrange return of your EpiPen/EpiPen Jr. device and obtain a replacement as soon as possible.
Pfizer Canada is also advising patients and caregivers to keep the affected EpiPen/EpiPen Jr. auto-injectors until a replacement is obtained.
In the event that a life-threatening allergic reaction (anaphylaxis) occurs before you can obtain a replacement, use your EpiPen/EpiPen Jr. product as directed by your healthcare provider and then seek emergency medical attention.
Speak with your healthcare professional if you are concerned about your health.
Contact Pfizer Canada at 1-866-9Pfizer (1-866-973-4937) or CorporateAffairsCanada@pfizer.com for more information on the recall.
Report adverse events to health products to Health Canada by calling toll-free at 1-866-234-2345, or by reporting online, by mail or by fax.
Report complaints about health products to Health Canada by calling toll-free at 1-800-267-9675, or complete an online complaint form.

Where Sold

Worldwide

Traders Selling Product

Various locations.

Official Reference

RA-62872

Organisation Name

Pfizer Canada
1-866-973-4937