News Category: Press release
Users advised to exchange affected pens at their pharmacy or clinic
The Health Products Regulatory Authority (HPRA) today advises that Meda Health Sales Ireland Ltd is recalling one lot (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 identified in a component part. Anyone who possesses 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.
The affected product and lot are:
| Product | Lot (Batch) Number | Expiry Date |
| Epipen 300mcg | 5FA665G | 05 2017 |
Advice to Patients and Carers:
- Check the lot number on all Epipens in your possession. If you identify an Epipen from the affected lot, please return it to your pharmacy, where a replacement, unaffected pen will be provided free-of-charge.
- As well as pens directly in your possession, please ensure that you also check any Epipens stored in other locations such as schools or workplaces.
- 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.
How to Identify the Lot Number
- The lot number can be found on the parts of the label and carton pictured below.
(Please also find link to image - Epipen - Precautionary recall image 21.03.2017)
- 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.
- No other brand of pens is impacted by this recall.
Epipen is administered through a pre-filled pen, or autoinjector. The reason for the recall is that a defect in a component part of the autoinjector was observed in a small percentage of pens from lot 5FA665G. This may lead to failure of the firing mechanism and, therefore, failure of administration of the potentially life-saving medicine.
The HPRA considers that the quality defect issue could potentially affect a very small number of pens. It states it has received no reports from patients or the medical profession in Ireland of injection failure associated with this lot of product.
Epipen is indicated as an emergency supportive therapy to treat severe anaphylaxis in children and adults. The HPRA wishes to remind patients that, in line with current medical guidelines, it is advised that they continue to carry two pens at all times. In addition, patients should seek immediate medical attention following administration of any autoinjector.
The HPRA will continue to liaise with Meda Health Sales and closely monitor the recall. It will provide further updates as necessary on www.hpra.ie.
Should patients have any concerns in relation to this matter, they should consult their doctor or pharmacist.
ENDS
For Further Information
Weber Shandwick PR (01) 679 8600
Siobhan Molloy / Rachel Galligan 086 817 5066 / 087 7919901