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Reason:
A recent retrospective analysis of pooled clinical trial data showed that the incidence of cardiovascular ischemic events in patients taking Zelmac was higher than in those taking placebo.
Letters were dispatched to doctors, pharmacies, and hospital pharmacies commencing 4 April 2007.
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.
