Apohealth children’s paracetamol for 1 to 5 years, children’s paracetamol for 6 to 12 years, and children’s ibuprofen for 6 months to 12 years

Recall - risk of plastic fragments breaking from bottle and being ingested

7 October 2015

Consumers and health professionals are advised that Apotex, in consultation with the TGA, is recalling two batches each of Apohealth children 's paracetamol for 1 to 5 years, children 's paracetamol for 6 to 12 years, and children's ibuprofen for 6 months to 12 years.

It has been identified that the bottle grooves that secure the lids on these products could break off during opening.

There is a risk that small pieces of plastic could be ingested if the issue is not identified by the user, potentially posing a choking hazard.

The affected products are 200 ml bottles with the following batch numbers:

  • Apohealth children 's paracetamol for 1 to 5 years – IA50283 and IA50321 (both with expiry 02/2017)
  • Apohealth children 's paracetamol for 6 to 12 years – IA50254 and IA50257 (both with expiry 02/2017)
  • Apohealth children 's ibuprofen for 6 months to 12 years – IA50405 and IA50406 (both with expiry 09/2017).

Bottles of Apohealth children’s paracetamol for 1 to 5 years, Apohealth children’s paracetamol for 6 to 12 years, and Apohealth children’s ibuprofen for 6 months to 12 years.

Bottle of Apohealth Childrens Paracetamol for 1-5 years Bottle of Apohealth Children's Paracetamol for 6-12 years Bottle of Apohealth Children's Ibuprofen 6 months to 12 years

Paracetamol is used to relieve pain and fever. Ibuprofen can be used to relieve pain and fever, and also to reduce inflammation.

The same issue affected other products manufactured in the same facility. Further information about other affected products is available on the TGA website.

No other batches of Apohealth children 's paracetamol for 1 to 5 years, Apohealth children 's paracetamol for 6 to 12 years, or Apohealth children 's ibuprofen for 6 months to 12 years are known to be affected.

Information for consumers

If you or someone you care for is using Apohealth children 's paracetamol for 1 to 5 years, Apohealth children 's paracetamol for 6 to 12 years, or Apohealth children 's ibuprofen for 6 months to 12 years, please be aware of this issue.

If you have Apohealth children 's paracetamol for 1 to 5 years, Apohealth children 's paracetamol for 6 to 12 years, or Apohealth children 's ibuprofen for 6 months to 12 years, check the batch number (displayed on the side of the carton and on the bottle label).

If you have a bottle with batch number IA50283 or IA50321 (Apohealth children 's paracetamol for 1 to 5 years), IA50254 or IA50257 (Apohealth children 's paracetamol for 6 to 12 years), or IA50405 or IA50406 (Apohealth children 's ibuprofen for 6 months to 12 years), return the medicine to the place of purchase for refund or replacement. In the meantime do not use the affected medicine.

If you have any questions or concerns about this issue, speak to your health professional. Alternatively, you can call Apotex on 1800 276 839.

Information for health professionals

If you are treating a patient who is using Apohealth children 's paracetamol for 1 to 5 years, Apohealth children 's paracetamol for 6 to 12 years, or Apohealth children 's ibuprofen for 6 months to 12 years, advise them or their carers of this issue.

If they have a bottle with batch number IA50283 or IA50321 (Apohealth children's paracetamol for 1 to 5 years), IA50254 or IA50257 (Apohealth children 's paracetamol for 6 to 12 years), or IA50405 or IA50406 (Apohealth children 's ibuprofen for 6 months to 12 years), advise them to return the medicine to the place of purchase for refund or replacement. Alternatively, they can call Apotex on 1800 276 839.

In the meantime, advise them to not use medicine from the affected batches.

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.