Level: | Consumer |
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Class: | II |
Reference: | RC-2009-RN-00228-3 |
Date agreed: | 02 April 2009 |
Product: | DITHRASAL 1% dithranol 10mg/g ointment tube DITHRASAL 2% dithranol 20mg/g ointment tube |
Sponsor: | Dermatech Pty Ltd |
Contact: | 1800 818 220 - Customer Service |
Reason: | The product contains higher than permitted levels of an impurity which may impact on the long term safety of the medicine. |
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.