ALPHAPHARM, in consultation with the Therapeutic Goods Administration (TGA), has announced it is recalling four batches of EpiPen 300 microgram adrenaline injection syringe auto-injectors, due to the potential failure to activate or the need to apply increased force to activate the device.
Pharmacies are to be the point of return for a refund or exchange from a different, unaffected batch free of charge, the TGA said.
EpiPens from the four affected batches have been said to 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, all with an Apr 2017 expiry, are 5FA665, 5FA6651, 5FA6652 and 5FA6653.
The TGA said there had been two confirmed reports of auto-injectors from these batches failing to activate correctly world-wide from around 80,000 devices distributed.
If this were to happen, there is a risk that the patient may not receive the appropriate dose of adrenaline in a timely manner or may not even get any adrenaline at all, with potential life-threatening consequences such as anaphylactic reactions.
The TGA was very specific about no other batches of EpiPen, including EpiPen Jr 150 microgram adrenaline injection syringe auto-injectors, being affected by this issue and were therefore not subject to this recall.
Any questions or concerns around this issue should be addressed to Alphapharm on 1800 274 276.
The above article was sent to subscribers in Pharmacy Daily's issue from 21 Mar 17
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