EpiPen recall 2

Recall | Medicines | 12/04/2017

The marketing authorization holder has informed its supplied customers about the extended voluntary recall of additional EpiPen batches in a letter dated April 12, 2017. There is a very low probability that the auto-injector does not work correctly. Worldwide, there were two customer complaints outside of Austria where the pen failed to trigger during an intended use. Therefore, the voluntary recall of 23.03.2017 is extended to include additional batches.

Name of the medicinal product EpiPen 300 Mikrogramm Injektionslösung in einem Fertigpen
EpiPen Junior 150 Mikrogramm Injektionslösung in einem Fertigpen
Marketing authorisation number(s) 1-22473 (EpiPen 300 Mikrogramm)
1-22472 (EpiPen Junior 150 Mikrogramm)
Marketing authorisation holder Meda Pharma GmbH
Batch number(s) 6FA292W, 6FA293AA (EpiPen 300 Mikrogramm)
5ED824P (EpiPen Junior 150 Mikrogramm)
Classification of the recallI
BASG reference number INS-640.001-2067
Email

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