"This recall is due to the potential that these devices may contain a defective part that may result in the devices' failure to activate", the FDA said in a news release.
The products covered by the recall were distributed by Pfizer Canada between November 2015 and February 2016.
Mylan said it was expanding a recall of its EpiPen allergy injection to some lots of the device that have been distributed in the US, after defects were found that could keep the injectors from working in an emergency. Furthermore, all patients should take comfort in knowing that the whole of this recall is being conducted with full and open supervision of the United States Food and Drug Administration.
The manufacturer is recalling 13 lots of both the EpiPen and EpiPen Jr.
The injection is used to counteract risky allergic reactions, such as those from bee stings or food allergies.
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UPI reported that the recalled EpiPen (0.3 mg) and EpiPen Jr.
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.
This voluntary recall is being conducted with the knowledge of FDA.
Patients should keep the injector in their possession until they have access to the replacement product.