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| Level: | Consumer |
|---|---|
| Class: | II |
| Reference: | R2004/1009 |
| Date agreed: | 01 September 2004 |
| Product: | Mavala Eyelite eye drops |
| ARTG number: | AUST R 12374 |
| Batch number: | All batches |
| Sponsor: | Apisant Pty Ltd |
| Contact: | (02) 9643 2444 Angela Carroll |
| Reason: | The product fails to meet the relevant standard for preservative efficacy. |
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.