Alphapharm Pty Ltd — EPIPEN 300 microgram (µg) Adrenaline Injection Syringe Auto-Injector (AUST R 42978)


Identifying features

Batch numbers: 5FA665, 5FA6651, 5FA6652, 5FA6653 with expiry date April 2017

What are the defects?

There is a potential that these devices may contain a defective part that may result in the device failing to activate or requiring increased force to activate.

What are the hazards?

The failure of the auto-injector to activate may result in patients not receiving the required dose of adrenaline, causing the worsening of symptoms of anaphylaxis or anaphylactic reactions, which could be life threatening.

What should consumers do?

Consumers should check if they have a 300 µg EpiPen® (yellow carton and label) and if so, check the batch number and expiry. The batch number and expiry can be found on the label of the pen or on the end of the carton.

If the EpiPen® 300µg has the following batch numbers: 5FA665, 5FA6651, 5FA6652 or 5FA6653 and an expiry of Apr 17, it needs to be replaced with a new one as soon as possible.

Consumers should return it to their pharmacist who will replace the EpiPen® 300µg from the affected batch with an EpiPen® 300µg from a different batch at no cost.

Consumers must keep their current EpiPen® until they get a replacement and use it if required.

At this time, EpiPen® Jr 150µg Adrenaline Injection Syringe Auto-Injectors and all other batches of EpiPen® 300µg Adrenaline Injection Syringe Auto-Injectors are unaffected and are not subject to this recall.

Alphapharm Pty Ltd
Where the product was sold
Dates available for sale
  • 29 January 2016 - 16 February 2016

Recall advertisements and supporting documentation

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category