Extended recall of EpiPen 300 micrograms and EpiPen Junior 150 micrograms solution for injection in a prefilled pen (epinephrine)

Safety warnings | Medicines | 12/04/2017

EpiPen 300 microgram solution for injection in a ready-to-use pen (epinephrine) and EpiPen Junior 150 microgram solution for injection in a ready-to-use pen (epinephrine) have been approved under the MRP/DCP procedure since March 30, 1998 for the emergency treatment of severe allergic reactions (anaphylaxis) to e.g. insect stings or bites, food, drugs and other allergens, as well as for idiopathic or exercise-induced anaphylaxis.

Meda Pharma GmbH received two customer complaints worldwide (outside of Austria) regarding EpiPen 300 microgram solution for injection in a ready-to-use pen, reporting improper functioning of the auto-injector. Specifically, in these rare cases, the pen failed to trigger during an intended use.

In Austria (following the recall previously issued on March 23, 2017 for lot number 5FA665N), lots with the Lot numbers 6FA292W, 6FA293AA (EpiPen 300 micrograms), usable until 30.09.2017 and 5ED824P (EpiPen Junior 150 micrograms), usable until 04/30/2017, are affected.

Measures at EU level

A risk class 1 recall down to the patient level has been proposed(http://www.ema.europa.eu,

Compilation of Community Procedures on Inspections and Exchange of Information).

Situation in Austria

In Austria, the following affected medicinal product is approved:

EpiPen 300 micrograms solution for injection in a ready-to-use pen.
EpiPen Junior 150 microgram solution for injection in a ready-to-use pen

The BASG has not received any notification from Austria regarding the affected batches from the period in question.

Recommendations of the BASG

Recommendations for health care professionals:

Block any stockpiles.
As a customer of Meda Pharma GmbH, as a wholesaler or pharmacy, please inform, if necessary, all the places you supply and retrieve the affected batches from them.
Please report any suspected case of an adverse reaction related to this quality defect via the national reporting system:

Federal Office for Safety in Health Care Traisengasse 5, 1200 Vienna Fax: + 43 (0) 50 555 36207 Website: http://www.basg.gv.at/

Recommendations for patients:

In accordance with the valid instructions for use, the recommendation to always carry two pens should be observed.
Patients who have already successfully used an EpiPen of the affected batches need not worry in this case.
Patients carrying an EpiPen of the affected batches are requested to return it to the nearest pharmacy. They will receive a replacement free of charge.