| Level: | Consumer |
|---|---|
| Class: | I |
| Reference: | R2003/66 |
| Date agreed: | 21 January 2003 |
| Product: | Travacalm Original Tablets Blister pack |
| ARTG number: | AUST R 78192 |
| Batch number: | 77164, 78586 and 79954 |
| Expiry | Various |
| Sponsor: | Key Pharmaceuticals Pty Ltd |
| Contact: | 02 9736 3811 (Ms Sonya Sparre) |
| Reason: | The product is being recalled following a number of reports of excess side effects related to the active ingredient. |
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.
Product types