Batch of life-saving EpiPens recalled due to ‘quality defect’

by Eilish O’Regan

People who rely on EpiPens to give them a life-saving injection in the event of a serious allergic reaction are being asked to check their lot number due to the recall of some stocks.

The Health Products Regulatory Authority (HPRA) said Meda Health Sales Ireland Ltd is recalling one batch of Epipen 300mcg Pre-filled Pens, used for the emergency treatment of acute allergic (anaphylactic) reactions.
EpiPens from the affected lot may fail to provide an injection of medicine when used, due to a quality defect issue found in a component part.

Anyone who has an EpiPen for their own use or for someone in their care is urged to check for lot number 5FA665G and to ensure affected pens are immediately replaced.
Lot 5FA665G includes a total of 998 Epipens supplied to the Irish market and it is estimated that the defect is associated with only a small percentage of pens in the lot.

If you identify an EpiPen from the affected lot, you should return it to your pharmacy, where a replacement, unaffected pen will be provided free-of-charge.
EpiPens stored in other locations such as schools or workplaces are also urged to be checked.

If you are in possession of an EpiPen with a lot number not listed, then the pen is unaffected and you do not need to take any action.
In line with existing medical guidelines, it is advised that patients continue to carry two pens at all times.

Only EpiPens from lot 5FA665G are being recalled. If your pen has a different lot number, then you do not need to return it to your pharmacy.