EpiPens recalled after failing to activate

The EpiPen 300 microgram has been recalled by the TGA
The EpiPen 300 microgram has been recalled by the TGA

Those using life-saving anti-allergy EpiPens in the area have been warned to check their batch number after a product recall.

The Therapeutic Goods Administration (TGA) said 80,000 EpiPen 300 microgram adrenaline injection auto-injectors may contain a defective part and have been distributed worldwide. 

There had been two confirmed reports of the auto-injectors failing to activate correctly. 

EpiPens are used to counter severe allergic reactions such as food, medications and insect stings and bites. 

The TGA said on it’s website: “They 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.”

Alphapharm, who initiated the recall along with TGA, said in a statement online: “The failure of the auto-injector to activate may result in patients not receiving the required dose of adrenaline resulting in the worsening of symptoms of anaphylaxis or anaphylactic reactions, which could be life threatening.”

The TGA has advised that EpiPen users should check the batch number and expiry date on either the EpiPen’s label or on the end of its carton. 

EpiPen Batches Affected

Batch Number/Expiry

  • 5FA665/April 2017
  • 5FA6651/April 2017
  • 5FA6652/April 2017
  • 5FA6653/April 2017

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.

Alphapharm advises users keep affected auto-injectors until they are replaced and using them if required. They added that users should be mindful that they may need to apply more force than normal to activate it. 

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.


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