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Mavala Eyelite eye drops

Medicine recall

Level: Consumer Class: II
Reference: R2004/1009 Date: 1 September 2004
Product: Mavala Eyelite eye drops
ARTG number: AUST R 12374
Batch number: All batches
Sponsor: Apisant Pty Ltd
Phone: (02) 9643 2444 Angela Carroll
Reason: The product fails to meet the relevant standard for preservative efficacy.
Recall letters were dispatched on 31 August 2004. Recall notices will appear in newspapers on 2 September 2004.

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.

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