Recall: Lax-Sachets

recall regulatory

TGA and AFT Pharmaceuticals are recalling four batches due to incorrect instructions on the sachets

Consumers and health professionals are advised that AFT Pharmaceuticals, in consultation with the TGA, is recalling four batches of Lax-Sachets.

The affected batch numbers are 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.

The TGA asks pharmacists to be aware of this issue and advise patients accordingly if they seek advice.

If you have any unused stock of Lax-Sachets, please check to see if they are from an affected batch.

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.

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