PRA number
2017/15984
Published date
Product description
The following batches of EpiPen® 300 microgram (µg) Adrenaline Injection Syringe Auto-Injectors (AUST R 42978) used for the treatment of allergic emergencies (anaphylaxis)):
Batch number 5FA665 Expiry Apr 17
Batch number 5FA6651 Expiry Apr 17
Batch number 5FA6652 Expiry Apr 17
Batch number 5FA6653 Expiry Apr 17
Batch number 5FA665 Expiry Apr 17
Batch number 5FA6651 Expiry Apr 17
Batch number 5FA6652 Expiry Apr 17
Batch number 5FA6653 Expiry Apr 17
Reasons the product is recalled
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.
The hazards to consumers
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 consumers should 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.
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.
Supplier
Alphapharm Pty Ltd
Where the product was sold
Nationally
International
Dates available for sale
-
Recall advertisements and supporting documentation
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.