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| Level: | Consumer |
|---|---|
| Class: | II |
| Reference: | RN-2007-0361 |
| Date agreed: | 06 June 2007 |
| Product: | Combantrin Suspension 50mg/mL (60mL bottle) |
| ARTG number: | 10747 |
| Batch number: | 87255 - 60mL bottle |
| Sponsor: | Johnson & Johnson Pacific Pty Ltd (the labelling shows Pfizer Consumer Healthcare as the distributor) |
| Contact: | Customer Service Centre - 1800 733 821 |
| Reason: | The sponsor has identified an increased number of complaints regarding the ability to resuspend Combantrin Suspension. This can give rise to dosing errors. |
*Press advertisements will appear in newspapers nationally on Friday 8 June 2007*
Letters are expected to be dispatched by the sponsor within two working days of the agreed date.
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.