DUROGESIC® 50 microgram/h fentanyl transdermal patches

Medicine recall

Published

7 October 2005

Level:	Consumer
Class:	I
Reference:	R2005/1313
Date agreed:	07 October 2005
Product:	DUROGESIC® 50 microgram/h fentanyl transdermal patches
ARTG number:	AUST R 60595
Batch number:	5CB2P00 & 5DB3D00
Sponsor:	Janssen-Cilag Pty Ltd
Contact:	1300 369 949 Medical Information Centre
Reason:	A small number of units from this batch could have incomplete sealing, which could allow some of the medication (a gel) inside the patch to leak out.

Recall letters were dispatched on 6 October 2005.

Please Note - Patients are being contacted directly by mail rather than through the use of press advertising.

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I & II recalls are considered to be safety related recalls.

Product types