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Recall - error in dosage/administration instructions
Consumers and health professionals are advised that AFT Pharmaceuticals, in consultation with the TGA, is recalling four batches of Lax-Sachets (batch numbers 7229215, 7229216, 7229217 and 7229219).
Lax-Sachets contain powder that, after being mixed with water, is taken orally to relieve constipation and treat faecal impaction.
It has been identified that there is an error in the dosage/administration instructions printed on the back of the sachets from the affected batches. It should be noted that the correct information is provided on both the product carton and the pack insert.
The incorrect directions on affected sachets read 'Administration: Each sachet should be dissolved in 1 litre of water.'
The correct instructions should be 'Administration: Each sachet should be dissolved in 125 mL water. For use in faecal impaction 8 sachets may be dissolved in 1 litre of water.'
Following the incorrect instructions on the sachets will result in a larger volume and more dilute solution to drink. This is unlikely to result in any harm to the user, but the effectiveness of the product may be reduced.
Information for consumers
If you or someone you provide care for uses Lax-Sachets, please check any unused sachets to see if they are from an affected batch (with batch number 7229215, 7229216, 7229217 or 7229219) or have the incorrect instructions on the sachets.
If you have affected products, return them to your pharmacy for a replacement or refund.
If you have any questions or concerns about this issue, talk to your health professional.
Information for health professionals
Please be aware of this issue and advise patients accordingly if they seek advice.
AFT Pharmaceuticals has written to suppliers to provide further information about this issue, including details of the recall procedure.
If you have any unused stock of Lax-Sachets, please check to see if they are from an affected batch (with batch number 7229215, 7229216, 7229217 or 7229219).
If you have affected products, quarantine them and follow the recall procedures to arrange replacement stock or credit.
If you have any questions or concerns about this issue, contact AFT Pharmaceuticals on 1800 2387 4276.
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.