ZELMAC tegaserod 6mg tablet blister pack
Medicine recall
| Level: | Consumer | Class: | I |
|---|---|---|---|
| Reference: | RN-2007-0221 | Date: | 4 April 2007 |
| Product: | ZELMAC tegaserod 6mg tablet blister pack | ||
| ARTG number: | 77325 | ||
| Batch number: | All batches | ||
| Sponsor: | Novartis Pharmaceuticals Pty Ltd | ||
| Phone: | 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. | ||
| 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.