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IMPORTANT INFORMATION ABOUT EPIPEN

11/10/19

Kirkland, QC, October 11, 2019 – Pfizer Canada is advising Canadians of very rare occurrences of EpiPen® (0.3 mg) and EpiPen Jr® (0.15 mg) auto-injector devices not easily sliding out of their plastic carrier tube. The number of EpiPen® or EpiPen Jr® auto-injectors which may have a defect that could cause a delay in release from the plastic carrier tube is estimated to be 2 auto-injectors out of every 1 million (0.0002%). Delayed or no treatment could lead to worsened patient condition, including possible fatal outcome. Consumers need to check their device now to confirm that it can be removed from the carrier tube with ease.

In a very limited number of observations (estimated 2 out of every 1 million units), a deformation on the open rim of the plastic carrier tube may be present. This defect may result in the device not sliding out of the tube as easily as expected. The issue is with the plastic carrier tube, and not with the device itself or the drug it delivers (epinephrine). This issue may affect any EpiPen auto-injectors currently on the market in Canada expiring prior to and including September 2020.

The root cause of this issue has been identified and corrective and preventative actions are in place. Detailed instructions, including pictures of the auto-injector, can be found below. We apologize for any inconvenience this issue could cause to patients and healthcare professionals.

Special Instructions for HEALTHCARE PROFESSIONALS

Special Instructions for CONSUMERS