PRA number
2007/9181
Published date
Product description
All batches.
What are the defects?
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.
What are the hazards?
Potentially life-threatening or a serious risk to health (Class I).
What should consumers do?
Letters were dispatched to doctors, pharmacies, and hospital pharmacies commencing 4 April 2007.
Supplier
Novartis Pharmaceuticals Pty Ltd
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.