A recall of the emergency anti-allergy medicine EpiPen has been expanded to include Canada, the U.S., Europe, Asia and South America because some of the devices administrating the allergy shots may not work.
Pfizer Canada issued a statement late Friday night saying it has decided to voluntarily recall two types of the epinephrine injection.
"In Canada, the recall impacts one lot (5GU763) of the 0.3 mg strength of EpiPen Auto-Injector expiring in May 2017 and one lot (5GR765) of the 0.15 mg strength of EpiPen Jr Auto-Injector expiring in March 2017," said the company, which distributes the product, manufactured by Meridian Medical Technologies in the U.S.
The products in lot 5GU763 were distributed by Pfizer Canada from January to March 2016. Those in lot 5GR765 were distributed from November 2015 to February 2016.
Pfizer said it's committed to replacing the recalled devices at no cost and has advised consumers who have them to contact its information line at 1-800-463-6001.
The U.S. Food and Drug Administration issued a notice on Friday alerting consumers to a voluntary recall of 13 lots of the auto-injector distributed from December 2015 through July 2016, saying some of the devices may fail to activate due to a defective part.
The U.S. distributor, Mylan Specialty, said it had two reports earlier in the month of the device failing.
Mylan didn't immediately respond to a question about how many devices are affected by the recall.
The problems could be potentially life-threatening, although Mylan described the incidence of the defects as "extremely rare."
The EpiPen is used to treat allergic reactions to certain food and bug bites.
A previous version of this story stated that Canada was not affected by the recall. In fact, Pfizer Canada issued a voluntary recall notice late Friday night.Apr 01, 2017 9:00 AM ET