PRA number
2007/9181
Published date
Product description
All batches.
Reasons the product is recalled
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.
The hazards to consumers
Potentially life-threatening or a serious risk to health (Class I).
What consumers should 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.