Product description
All batches.
See a list of details to help identify the product
Reason 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.
Details to help identify the product
Supplier running the recall
Novartis Pharmaceuticals Pty Ltd
Identifying product features
ARTG No. 77325.
Identifying numbers
Other identifying numbers
ARTG No. 77325.
Where the product was sold
Nationally
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2007/9181 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.