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ACETOPT 10% sulfacetamide sodium 100mg/mL eye drops bottle

Medicine recall

Level: Consumer Class: II
Reference: R2003/799 Date: 5 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
Phone: 1800 036 073 Customer Service
Reason: The product does not meet the required preservative efficacy test requirements.
Recall letters will be dispatched today, 5 August 2003. Press advertisement will appear in each State and Territory on 7 August 2003.

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.