GSK recalls from trade two batches of Children’s Panadol® 1-5 years Suspension

GSK is working with the Therapeutic Goods Administration (TGA) to recall two batches of Children’s Panadol^® 1-5 years Suspension from pharmacies and hospitals for quality reasons. This is not a consumer level recall.

These two batches were dispatched from GSK between September and November 2013 and are being recalled from pharmacies and hospitals as a precautionary measure. The identified batches are:

• Children's Panadol 1-5 years suspension (strawberry / 200mL) - (identified by JR130869 on the carton and 130869 on the bottle)
• Children's Panadol 1-5 years suspension (orange / 100mL) - (identified by JR130697 on the carton and 130697 on the bottle)

GSK has multiple quality controls in place and our extensive quality checks continue even when a product is in market. During our routine longer term testing, it was identified that a small proportion of bottles within two batches could have out of specification results, showing a higher amount of paracetamol than the permitted specification.

The increase in paracetamol may result in doses that are over the recommended and labelled doses, but this does not pose an immediate risk to children when the product is used according to the directions on the label. On this basis GSK, in consultation with the TGA, determined that a consumer level recall of these batches was not required.

“As always, consumers should ensure that they follow the dosing directions on the product label carefully. If they have any concerns that a child may have received too much Children’s Panadol^® they should seek medical advice immediately, or call the Poisons Information Centre (Australia 131 126),” said Vincent Cotard, GSK General Manager ANZ.

“Panadol is the most trusted pain reliever brand in Australia and our actions in this situation reflect this trust that consumers place on our product. Even if the risk is very low we will take every action to ensure our products meet all quality requirements,” Mr Cotard said.

If you have a bottle from one of the two affected batches or have any questions please contact the GSK Product Information team on 1800 650 123 (between 8.30am and 5.30pm EST).

No other Children’s Panadol^® products in the range are affected.

For more information about Children’s Panadol^® visit www.childrenspanadol.com.au.

When using Panadol^® ALWAYS READ THE LABEL. Use only as directed. For the temporary relief of pain and fever. Incorrect use could be harmful. Consult your healthcare professional if symptoms persist.

CHILDREN’S PANADOL is a registered trade mark of the GlaxoSmithKline group of companies.
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Readers Digest Trusted Brands survey Australia 2013.