The Health Products Regulatory Authority (HPRA) say Meda Health Sales Ireland Ltd is recalling one lot of Epipen 300mcg pre-filled pens.
These are used for the emergency treatment of acute allergic reactions.
The Epipens affected may fail to provide an injection of medicine when used, due to a defect 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.
It is estimated that the defect is associated with only a small percentage of pens in the lot.
The affected product and lot are:
- Product: Epipen 300mcg
- Lot (Batch) Number: 5FA665G
- Expiry Date: 05 2017
The lot number can be found on the parts of the label and carton. Only Epipens from lot 5FA665G are being recalled.
Image: HPRA
The HPSC say any affected pens should be returned to a pharmacy, where a replacement unaffected pen will be provided free-of-charge.
People are being reminded to ensure they also check any Epipens stored in other locations, such as schools or workplaces.