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.