Recall of "EpiPen 300 micrograms solution for injection in a ready-to-use pen".
EpiPen 300 micrograms solution for injection in a ready-to-use pen (epinephrine) has 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 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, the batch with batch number 5FA665N, usable until March 31, 2017, is affected.
Measures at EU level
A recall of risk class 1 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 drug product is approved: EpiPen 300 microgram solution for injection in a ready-to-use pen The BASG has not received any relevant notification from Austria regarding this batch 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 batch 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 batch 5FA665N do not need to worry subsequently in this case.
- Patients carrying a batch 5FA665N EpiPen are asked to return it to their nearest pharmacy no later than March 31, 2017. They will receive a replacement free of charge.
More information:
Official News 2017 - 03/23/2017, EpiPenQueries (technical): Dr. Christoph Baumgärtel, Tel: 050555/36004 Email: christoph.baumgaertel@ages.at Queries (for media): Communications Management, Tel: 050555/25000 Email: presse@ages.at
