| Level: | Consumer |
|---|---|
| Class: | II |
| Reference: | R2002/1084 |
| Date agreed: | 17 September 2002 |
| Product: | Calmo Drops |
| ARTG number: | AUST L15461 |
| Batch number: | A895 |
| Expiry | 12/04 |
| Sponsor: | Eagle Pharmaceuticals Pty Ltd |
| Contact: | 02 9899 6564 (Mr Rodney Roberts) |
| Reason: | Recovery of wrongly supplied goods pursuant to Section 30 of the Therapeutic Goods Act 1989. |
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.