| Level: | Consumer |
|---|---|
| Class: | I |
| Reference: | RN-2007-0221 |
| Date agreed: | 04 April 2007 |
| Product: | ZELMAC tegaserod 6mg tablet blister pack |
| ARTG number: | 77325 |
| Batch number: | All batches |
| Sponsor: | Novartis Pharmaceuticals Pty Ltd |
| Contact: | Novatis Medical Information & Communications - 1800 671 203 |
| 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. |
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.