Health Canada is recalling two batches of epinephrine auto-injector products used in the treatment of serious allergic reactions in children.
The agency says it's due to a manufacturing defect that may render the device ineffective at delivering the medication in an emergency.
Allerject, which is used in the emergency treatment of anaphylaxis, works by reversing the rapid and dangerous decrease in blood pressure and relaxing the muscles in the airway during an allergic reaction.
A Health Canada statement says the defect "can pose serious health risks to patients" and that anaphylaxis may cause death.
The affected product is the pre-filled, single-use auto-injector of 0.15 milligrams, which is intended for use in children weighing between 15 to 30 kilograms.
Parents of children using this product are advised to check the lot numbers and return all affected products to their pharmacy for replacements.
The medication was distributed by Sanofi-aventis Canada Inc. since June 1 and the lot numbers in question are 2857508, 2857505 and DIN 02382059.
The company says the two batches amount to 3,039 auto-injectors.