AFT Pharmaceuticals Pty Ltd — Lax Sachets
What are the defects?
Error in dosage/administration instructions.
There is an error in the labelling on the back panel of individual sachets of 4 batches of Lax Sachets with respect to the reconstitution information. The information on the carton and pack insert is correct.
- INCORRECT LABELLING - Administration: Each sachet should be dissolved in 1 litre of water.
- CORRECT LABELLING - 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.
What are the hazards?
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.
What should consumers do?
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.
Therapeutic Goods Administration is the responsible regulator for this recall.