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| Level: | Consumer |
|---|---|
| Class: | II |
| Reference: | R2004/1226-9 |
| Date agreed: | 01 October 2004 |
| Product: | VIOXX (Rofecoxib) tablets 12.5mg (AUST R 69872) VIOXX (Rofecoxib) tablets 25mg (AUST R 69871) VIOXX (Rofecoxib) oral suspension 12.5mg/5mL (AUST R 69870) VIOXX (Rofecoxib) oral suspension 25mg/5mL (AUST R 69869) |
| Batch number: | All batches |
| Sponsor: | Merck Sharp & Dohme Pty Ltd |
| Contact: | 1800 066 426 Customer Service Line |
| Reason: | The company has decided to recall VIOXX based on new information from a recent clinical study which showed that there was an increased risk of cardiovascular events such as heart attack and stroke beginning after 18 months of treatment, in the patients taking Vioxx at a dose of 25 mg once daily. |
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.