DUROGESIC® 50 microgram/h fentanyl transdermal patches
Medicine recall
| Level: | Consumer | Class: | I |
|---|---|---|---|
| Reference: | R2005/1313 | Date: | 7 October 2005 |
| Product: | DUROGESIC® 50 microgram/h fentanyl transdermal patches | ||
| ARTG number: | AUST R 60595 | ||
| Lot number: | 5CB2P00 & 5DB3D00 | ||
| Sponsor: | Janssen-Cilag Pty Ltd | ||
| Phone: | 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. | ||
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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. |
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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.