Mavala Eyelite eye drops

Medicine recall

Published

1 September 2004

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.

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.

Product types