PRA number
2017/16334
Published date
Product description
Lax Sachets contain powder that, after being mixed with water, is taken orally to relieve constipation and treat faecal impaction.
30 sachets per pack
Batch numbers 7229215, 7229216, 7229217 and 7229219 only
Expiry 12/2020
ARTG Number 202202
30 sachets per pack
Batch numbers 7229215, 7229216, 7229217 and 7229219 only
Expiry 12/2020
ARTG Number 202202
Reasons the product is recalled
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.
The hazards to consumers
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 consumers should 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.
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.
Supplier
AFT Pharmaceuticals Pty Ltd
Traders who sold this product
Pharmacies nationally
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.