Recall of Epipen batch due to defect

The pens may not provide an injection

Recall of Epipen batch due to defect

Image: HPRA

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.