Patient Level Recall of one lot of Epipen® 300 microgram autoinjector in Ireland.
MEDA is committed to the highest standards of patient safety and product quality.
Epipen® (Adrenaline Autoinjector) is an autoinjector containing adrenaline which is used for emergency treatment of severe allergic reaction (anaphylaxis), more than 1 million patients depend on this life-saving device in Europe.
Recently, MEDA received two complaints worldwide regarding the EpiPen® 300 microgram device for lot number 5FA665 from other markets than Ireland. In Ireland lot numbers 5FA665G is marketed expiring 31.5.2017.
On the basis of an investigation conducted by the manufacturer Meridian Medical Technologies (MMT), it has been observed that there may be a very small probability in Lot 5FA665G that the auto-injector may not work correctly. The reason for the recall in Ireland is that a defect in a component part of the autoinjector was observed in a small percentage of pens in this lot, on other markets.
This voluntary recall applies ONLY to Lot 5FA665G.
Patients who carry Epipen(s)® with Lot 5FA665G are requested to return the Epipen(s)® at the earliest opportunity to their dispensing pharmacy, where they will be given a replacement free of charge.
The lot number is printed onto the Epipen® and the carton box.