Two Lots of Allerject (0.15 mg / 0.15mL auto-injector) For Use In Children Recalled Due to Manufacturing Defect

Sanofi-aventis Canada Inc., in consultation with Health Canada, is recalling two lots (2857508 and 2857505) of Allerject (0.15 mg / 0.15 mL auto-injector) due to a manufacturing defect that may prevent the device from working properly. As a result of a manufacturing defect with the needle, the device may not deliver the epinephrine needed for emergency treatment of serious allergic reactions (anaphylaxis), which can pose serious health risks to patients. Anaphylaxis may cause death. The dosage strength for this pre-filled, single-use auto injector is intended for use in children weighing between 15 kilograms and 30 kilograms. The affected lots were distributed starting June 1, 2015.

The parents and caregivers of children using this product are advised to check the lot numbers of their Allerject (0.15 mg / 0.15 mL auto-injector) and return all affected product to their pharmacy for replacement auto-injectors with the same dosage of epinephrine. They should also speak with their pharmacists to ensure they properly understand how to use the replacement auto-injector if it is different from the one they have been using. Parents and caregivers of children using this product who have concerns about their child’s health should speak to their healthcare professional. Report any adverse events to Health Canada .