We are aware of an issue causing the title of some ARTG entries to disappear. We are investigating as a priority and hope to have this resolved as soon as possible.
| Level: | Consumer |
|---|---|
| Class: | II |
| Reference: | R2003/799 |
| Date agreed: | 05 August 2003 |
| Product: | ACETOPT 10% sulfacetamide sodium 100mg/mL eye drops bottle |
| ARTG number: | AUST 19641 |
| Batch number: | All batches |
| Sponsor: | Sigma Pharmaceuticals Pty Ltd |
| Contact: | 1800 036 073 Customer Service |
| Reason: | The product does not meet the required preservative efficacy test requirements. |
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.