June 13, 2015: Children's Allerject

Started by SilverLining, June 13, 2015, 07:41:29 PM

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SilverLining

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/53781a-eng.php

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.


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