EpiPen packaging may be defective, Health Canada warns — here’s how to tell

Health Canada is warning that some EpiPen and EpiPen Jr may have a defect in packaging that makes it difficult — or impossible — to remove the auto-injectors from the packaging.

Pfizer Canada alerted the public health agency to the issue, noting that the problem affects a “very small number of cases,” but it did not give an exact number.

The possible affected products are:

• EpiPen (0.3 mg) (DIN 00509558) products, with an expiry date between April 2018 and October 2019.
• EpiPen Jr (0.15 mg) (DIN 00578657) product, with an expiry date between April 2018 and October 2019.

In cases of faulty packaging, the auto-injectors “may not slide out of their carrier tube easily, or at all,” Health Canada warns. This could lead to delays or prevent life-saving treatment entirely.

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“According to the company, the device label has been improperly applied to a very small number of devices in a way that the device label may become stuck to the inside of the carrier tube,” Health Canada’s advisory read.

But Pfizer Canada has not recalled the affected products. Instead, it is urging Canadians to check their EpiPens beforehand or ask a pharmacist to test them.

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“Products are not being recalled by Pfizer (in agreement with Health Canada), because pharmacists and consumers can check devices themselves before an emergency situation arises to make sure they slide easily out of their carrier tube,” the company explained in a press release. 

To test whether an EpiPen is affected, consumers can try to slide their device from the carrier tube.

Health Canada explains how: “To check the device, flip open the carrier tube cap, gently turn the tube upside down and let the device slide out into your hand (do not shake or drop it). Visually inspect your device to make sure the device label has no unglued edges that may catch on the tube.”

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The advisory adds that consumers should not remove the blue safety release while inspecting the device. That would only be removed when the auto-injector is actually being used.

Once checked, the EpiPen can be returned back to the carrier tube and stored. If there is a problem, the device can be returned.

“If your device sticks or does not slide out easily from its tube, or the device label has unglued edges, return it to your pharmacist for replacement,” the health agency explains.

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Health Canada also reminded consumers in its advisory that there is a shortage of EpiPen supply, and that an alternate product Auvi-Q is available through an interim order.

In August, Health Minister Ginette Petitpas Taylor signed an interim order to allow the U.S.-approved Auvi-Q epinephrine auto-injectors to be imported into Canada due to the shortage.

More information on the alternate Auvi-Q auto-injectors is available on Health Canada’s website.

— With a file from The Canadian Press