Consumers and health professionals are advised that Alphapharm, in consultation with the TGA, is recalling four batches of EpiPen 300 microgram adrenaline injection syringe auto-injectors. EpiPens from affected batches can be returned to pharmacies for a refund or exchanged for one from a different, unaffected batch free of charge.

EpiPen is used in emergency situations to treat people who are having a severe allergic reaction (also known as anaphylaxis).

It has been identified that EpiPens from the four affected batches may contain a defective part that could result in the auto-injector failing to activate or a need to apply more force than normal to activate.

The affected batch numbers are:

Batch number Expiry

5FA665 April 2017

5FA6651 April 2017

5FA6652 April 2017

5FA6653 April 2017

There have been two confirmed reports of auto-injectors from these batches failing to activate correctly world-wide from approximately 80,000 devices distributed. The proportion of these auto-injectors that have been used is not known.

EpiPens are only used in emergency situations. In the unlikely event the auto-injector fails to activate correctly, there is a risk that the patient may not receive the required dose of adrenaline in a timely manner or they may not get the dose at all. If this happens, it could result in a worsening of the potentially life-threatening symptoms of anaphylaxis or anaphylactic reactions.

Please note that no other batches of EpiPen, including EpiPen Jr 150 microgram adrenaline injection syringe auto-injectors, are known to be affected by this issue and are not subject to this recall.

Information for consumers.

If you or someone you provide care for has an EpiPen 300 microgram adrenaline injection syringe auto-injector, check the batch number and expiry on either the label of the EpiPen or on the end of the carton.

[Demonstration of batch number location on EpiPen label and carton]

If your EpiPen is from batch 5FA665, 5FA6651, 5FA6652 or 5FA6653 (all of which expire in April 2017), return it to your pharmacy. Your pharmacist will replace the EpiPen from an affected batch with an EpiPen from a different, unaffected batch free of charge. Alternatively, if you have another unaffected EpiPen available, you can request a refund if you prefer.

While you are advised to return an affected EpiPen as soon as possible, you should keep your current auto-injector until you get the replacement, and use it if required (being mindful that you may need to apply more force than normal to activate it).

If you have any questions or concerns about this issue, talk to your health professional.

Information for health professionals.

If you are treating a patient who has an EpiPen 300 microgram adrenaline injection syringe auto-injector, advise them to check their product’s batch number and to return it to their pharmacy if it is from one of the affected batches.

Please advise patients that, while they should return an affected EpiPen as soon as possible, they should keep their current auto-injector until they get the replacement, and use it if required (being mindful that they may need to apply more force than normal to activate it).

As with all medical emergencies, patients and caregivers should be reminded to remain calm and to not hesitate to call 000 if necessary.

If you have any questions or concerns about this issue, contact Alphapharm on 1800 274 276.

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.