| Level: | Consumer |
|---|---|
| Class: | I |
| Reference: | R2003/795 |
| Date agreed: | 04 August 2003 |
| Product: | Flexitone tablets |
| ARTG number: | AUST L 70700 |
| Batch number: | 3156 |
| Expiry | 07/06 |
| Sponsor: | Nutrition Care Pharmaceuticals Pty Ltd |
| Contact: | 1800 034 445 Nutrition Care Pharmaceuticals |
| Reason: | This batch was formulated with the wrong active ingredient. The Oleoresin has been found to be of capsicum origin rather than Bosellia origin. The product thus has the potential to cause gastric irritation and burning. |
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.