Epipen 300 Microgram Adrenaline Injection Syringe Auto Injectors

Alert - reports of expired EpiPen devices supplied in cartons within expiry

11 March 2016

A small number of reports have been received of discrepancies being noted between the batch numbers and expiry dates on EpiPen Adrenaline Auto-Injector cartons and the batch numbers and expiry dates on the EpiPen devices inside the cartons. The reports have come from pharmacies in a small area of Victoria.

As a precautionary measure the product's sponsor, Alphapharm, in consultation with the TGA, is urging users of EpiPen Adrenaline Auto-Injectors to check that the expiry date on each EpiPen device is the same as that on the carton, along with a timely reminder that EpiPen devices must not be used beyond the expiry date.

Alphapharm advises that the important action for anyone with an EpiPen is to check the expiry date on the actual EpiPen device. If the pen is in date, and it has been kept under recommended storage conditions, there are no concerns about the effectiveness of the product.

Location of expiry date on EpiPen Location of expiry date on box
An Epipen with the location of the expiry date highlighted and the date stamp on the top of the carton.

Information for consumers

If you or somebody you care for uses EpiPen Adrenaline Auto-Injectors, you should check the expiry date on each EpiPen device and compare it with the information on the carton. If these dates do not match, return the product to the place of purchase for replacement.

EpiPen Adrenaline Auto-Injectors must not be used beyond its expiry date. If you have an expired EpiPen, you must replace it with an EpiPen within expiry as soon as possible.

Contact Alphapharm by telephone on 07 3000 6258 or 07 3000 6294 or email if you require additional information.

Information for health professionals

If you are treating a patient who uses EpiPen Adrenaline Auto Injectors, alert them to this issue and advise them to check the expiry dates on both the packaging and individual pens. If the dates do not match, advise them to return the pens to the place of purchase for replacement.

Advise them to replace and not use out-of-date pens.

If you are a pharmacist supplying EpiPen Adrenaline Auto Injectors, you are advised to check the expiry dates on the pens and cartons before supplying them to consumers.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.