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Which epi pens were recalled?
Here are some of the details from Health Canada.
Two Lots of Allerject (0.15 mg / 0.15mL auto-injector) For Use In Children Recalled Due to Manufacturing DefectSanofi-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.
Is Your Child's Epi Pen One of These?The affected lots were distributed starting June 1, 2015. Products affected Allerject (0.15 mg / 0.15 mL auto-injector), lots 2857508 and 2857505, DIN 02382059. The affected lots were distributed starting June 1, 2015.
What You Should DoThe 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.
Call toll-free at 1-866-234-2345 Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax at the link below in related links.
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- Epipen Recall Notice http://adf.ly/4009826/epi-pen-recall-notice
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