Children's Panadol Baby Drops syringe - recall

Recall - incorrectly placed dosing indicators

26 November 2013

This update provides further specific information about the recall of Children's Panadol Baby Drops being undertaken by GlaxoSmithKline (GSK), in conjunction with the TGA, for a misaligned dosing syringe that could lead to accidental overdoses.

The TGA issued a safety advisory regarding this issue on 22 November. GSK also issued a Safety Alert to consumers and hospitals and undertaking a retail level recall from pharmacies. Consumers and hospitals should check any Children's Panadol Baby Drops syringes they have. If the dosing indicator does not begin from the bottom of the syringe near the tip, do not use the syringe to measure out medicine (see image).

Syringe with misaligned label compared to correctly placed label

The active ingredient in Children's Panadol Baby Drops is paracetamol. Paracetamol has been used in Australia for the relief of pain and fever since the 1950s and is available in many different forms for adults and children.

Paracetamol is safe and effective when taken as directed on the label. However, if taken either in overdose or in amounts that exceed the recommended dose for more than a few days, the unwanted effects can be severe.

The problem only applies to the dosing syringes supplied with Children's Panadol Baby Drops and does not affect the quality of the accompanying medicine. Other products and dosing devices in the Children's Panadol range are not affected, including Children's Panadol Baby Drops that contain a dropper as the measuring device.

Information for consumers

Consumers should check any Children's Panadol Baby Drops syringes they have. If the dosing indicator does not begin from the bottom of the syringe near the tip do not use the syringe to measure out medicine (see image above).

If you have any concerns you should take the product to your local pharmacy for checking prior to use.

What parents and guardians should know about paracetamol overdose:

  • The harmful effects of large amounts of paracetamol on the liver are usually delayed, so children may feel well for the first day after an overdose but become very sick after that.
  • Immediate medical management is required in the event of overdose, even if symptoms of overdose are not present.
  • If you think you have given too much paracetamol (overdose), contact the Poisons Information Centre (Telephone 131 126) or your doctor, or go to the nearest hospital emergency department. Do this even if your child does not seem sick.
  • Don't give paracetamol to infants, children or adolescents for more than 48 hours unless advised by a doctor.

Additional information for consumers regarding the consequences of using a faulty syringe and the risks of overdose can be found in the TGA's safety advisory.

Information for health professionals

For community pharmacists

Advise parents and caregivers of this issue and offer to check any products they may have.

Offer to supply an alternative dosing measure.

Return all stock of Children's Panadol Baby Drops to GSK for replacement. Contact GSK on 1800 650 123 for instructions on the process to be followed.

If any misaligned syringes are found, ask if you can retain them and contact GSK to arrange pick up.

For hospital staff

Hospitals should check all dosing syringes accompanying Children's Panadol Baby Drops for this issue.

If any misaligned syringes are found, retain them and contact GSK on 1800 650 123 to arrange pick up. This will allow GSK to further investigate the cause of this issue.

For all health professionals

If recommending the use of Children's Panadol Baby Drops, advise parents and caregivers to be aware of this issue and to check any accompanying syringes.

Advise them not to use any syringes that are misaligned.

Be alert to the possibility that accidental overdose may exist when the product has been used more frequently or for longer than recommended.

A close visual inspection of a faulty syringe compared to a non-faulty syringe indicated that an additional amount of 0.75-0.8mL would be delivered by the faulty syringe.

It cannot be assumed that people using the product will notice the faulty syringe, as they may be using the product for the first time and may not have experience with administering medications via syringe.

Overall, if the product is used as directed for less than 48 hours, the likelihood of infants developing hepatoxicity is low but not negligible.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.