PRA number
2013/13888
Published date
Product description
GlaxoSmithKline (GSK), in consultation with the TGA, is recalling two batches of Children's Panadol 1-5 years suspension from pharmacies and hospitals as a small proportion of bottles contain higher levels of paracetamol than specified.
For more detailed information in relation to the recall, please visit the Therapeutic Goods Administration website.
For more detailed information in relation to the recall, please visit the Therapeutic Goods Administration website.
Reasons the product is recalled
The higher levels of paracetamol in the two affected batches may result in doses that are over the recommended and labelled doses but not to the extent that they pose risks to children when the product is used according to the directions on the label.
The hazards to consumers
Incorrect dosage may result in illness.
What consumers should do
Parents and carers should ensure that they follow the dosing instructions on the label.
If you have given more paracetamol than recommended above, contact the Poisons Information Centre (telephone 131126) or your doctor, or go to the nearest hospital emergency department. Do this even if your child does not seem sick.
If you have a bottle from one of the two affected batches and still have concerns, you can contact GSK on 1800 650 123 (between 8am and 8pm EST). GSK will either organise for a replacement product to be sent to you or, if urgent, GSK can arrange for you to pick up a replacement product from your local pharmacy. Alternatively a refund can be provided.
If you have given more paracetamol than recommended above, contact the Poisons Information Centre (telephone 131126) or your doctor, or go to the nearest hospital emergency department. Do this even if your child does not seem sick.
If you have a bottle from one of the two affected batches and still have concerns, you can contact GSK on 1800 650 123 (between 8am and 8pm EST). GSK will either organise for a replacement product to be sent to you or, if urgent, GSK can arrange for you to pick up a replacement product from your local pharmacy. Alternatively a refund can be provided.
Supplier
GlaxoSmithKline Australia Pty Ltd
Traders who sold this product
Sold in pharmacies over the counter (OTC) and available for use in hospitals
Where the product was sold
Nationally
Recall advertisements and supporting documentation
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.