Pfizer Canada issued a statement late Friday night saying it has made a decision to voluntarily recall two types of the epinephrine injection. EpiPens affected under the new recall were distributed in the US between December 17, 2015, and July 1, 2016.
The FDA and Mylan say the recall is due to reports of a potential defect in 13 lots of the device that may cause the EpiPen to unsuccessfully activate in an emergency situation.
A dozen lot numbers of EpiPens, including the specially formulated half doses known as EpiPen Jr., are included in the recall.
Mylan got a lot of criticism past year when the price for its product increased by over 400 percent. Mylan distributes EpiPen auto-injector devices to countries like Australia, Denmark, Norway, and the United States (of course).
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 company's CEO had to testify in front of Congress over the hike.
This, of course, could have significant health consequences for patients who are amid a life-threatening allergic reaction.
Consumers should keep and use their EpiPen until they have a replacement.
The company said more than 100,000 products that could be affected were distributed in Canada.