Pharmacy Care children's paracetamol suspension for 6 to 12 years and Pharmacy Care children's paracetamol elixir for 1 to 5 years

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

3 August 2015

Consumers and health professionals are advised that Cipla Australia (sponsor) and Sigma (brand owner), in consultation with the TGA, are recalling one batch of Pharmacy Care children's paracetamol suspension for 6 to 12 years and one batch of Pharmacy Care children's paracetamol elixir for 1 to 5 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 batch numbers IA50046 (Pharmacy Care children's paracetamol suspension for 6 to 12 years) and IA50002 (Pharmacy Care children's paracetamol elixir for 1 to 5 years), both with expiry dates of 11/2016.

Bottle of Pharmacy Care children's paracetamol suspension for 6 to 12 yearsBottles of Pharmacy Care children's paracetamol suspension for 1 to 5 years

Bottles of Pharmacy Care children's paracetamol suspension for 6 to 12 years and Pharmacy Care children's paracetamol elixir for 1 to 5 years.

Paracetamol is used to relieve pain and fever.

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

No other batches of Pharmacy Care children's paracetamol suspension for 6 to 12 years or Pharmacy Care children's paracetamol elixir for 1 to 5 years are known to be affected.

Information for consumers

If you or someone you care for is using Pharmacy Care children's paracetamol suspension for 6 to 12 years or Pharmacy Care children's paracetamol elixir for 1 to 5 years, please be aware of this issue.

If you have Pharmacy Care children's paracetamol suspension for 6 to 12 years or Pharmacy Care children's paracetamol elixir for 1 to 5 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 IA50046 (Pharmacy Care children's paracetamol suspension for 6 to 12 years) or IA50002 (Pharmacy Care children's paracetamol elixir for 1 to 5 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 Sigma on 1300 132 293.

Information for health professionals

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

If they have a bottle with batch number IA50046 (Pharmacy Care children's paracetamol suspension for 6 to 12 years) or IA50002 (Pharmacy Care children's paracetamol elixir for 1 to 5 years), advise them to return the medicine to the place of purchase for refund or replacement. Alternatively, they can call Sigma on 1300 132 293.

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.