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| Level: | Consumer |
|---|---|
| Class: | I |
| Reference: | R2003/92 |
| Date agreed: | 30 January 2003 |
| Product: | Travacalm HO hyoscine hydrobromide 300 micrograms tablets strip pack |
| ARTG number: | AUST R 68450 |
| Batch number: | 77163, 79376 |
| Expiry | Various |
| Sponsor: | Key Pharmaceuticals Pty Ltd |
| Contact: | 1800 653 373 (Customer Relations) |
| Reason: | The product is being recalled because the tablets do not conform to the uniformity of content specification. This means that some tablets contain the active ingredient in doses much higher than should be there, creating the risk of unintentional overdosing. |
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.