Ionsys (fentanyl)

Recall | Medicines | 29/09/2008

The following quality defect has been identified in the drug product Ionsys (Fentanyl) 40 microgram per dose iontophoretic transdermal system:

A defect in the IONSYS systems may potentially cause the system to self-activate.

See related files.

Name of the medicinal product Ionsys (Fentanyl) 40 Mikrogramm pro Dosis iontophoretisches transdermales System
Marketing authorisation number(s) EU/1/05/326/001
Marketing authorisation holder Janssen-Cilag International NV
Batch number(s) Alle Chargen
BASG reference number 640.126/2008

Further inquiry note