What should Canadian consumers do if they have Allerject?
Patients with an Allerject device are being asked to immediately contact their pharmacy to obtain an alternate epinephrine auto-injector. In the absence of availability of an alternate epinephrine auto-injector, patients are instructed to retain their Allerject device until an alternate auto-injector is available. We are asking customers and pharmacists to limit replacement of Allerject to one unit per customer unless otherwise directed by their physician. If you have additional questions about this recall, you can contact the Allerject Call Center at 1 855-405-4321. If your pharmacist has specific questions relating to product return logistics, they should contact Sanofi Customer Service at 1-800-265-7927.
Is a prescription required to receive a replacement for my Allerject?
No prescription is required to receive a replacement epinephrine auto-injector.
Will patients have to pay for their replacement medication?
Sanofi is collaborating with retail pharmacy chains and pharmacists to ensure patients receive an alternate device without additional cost to the patient.
What drug can be substituted as the replacement for Allerject?
EpiPen is the only epinephrine auto-injector currently available in Canada.*
*Twinject and Anapen are approved in Canada but not currently marketed.
What is the potential or theoretical risk if the recalled product is administered to patients?
There is no risk associated with the drug itself, but there is an issue with the device that may potentially affect delivery of the required amount of epinephrine. If a patient experiencing a serious allergic reaction (i.e. anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life threatening condition
You say this is a voluntary recall, but did Health Canada advise you to recall Allerject?
During a routine manufacturing quality review, issues with the Allerject device were discovered at a contract manufacturer that may potentially affect the delivery of the required amount of drug. As a precautionary measure and with the knowledge of Health Canada and the FDA, Sanofi issued a voluntary Type I (Class I in the US) recall of all Allerject and Auvi-Q.
Have you alerted healthcare professionals?
Yes, we have actively been in contact with healthcare professionals.
What should a patient do if the Allerject product they have fails to work?
Call 911 and immediately seek emergency medical services, in accordance with current product labelling. Any event that may be related to the use of this product should be reported either to Sanofi Canada or to MedEffect Canada’s website.
Do you expect to ultimately reintroduce this product in Canada? If so, when?
Sanofi’s priority and focus is to ensure patient safety. The company has instructed its contract manufacturer to temporarily discontinue manufacturing and for all distribution to cease until all product issues are resolved. We will continue to communicate the status of Allerject availability in a timely manner.