Amcal children's paracetamol elixir for 1 to 5 years, Amcal children's paracetamol suspension for 6 to 12 years, Amcal ibuprofen suspension for children, and Amcal cetirizine oral solution

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

25 October 2015

Consumers and health professionals are advised that Cipla Australia (sponsor) and Sigma (brand owner), in consultation with the TGA, are recalling:

  • two batches of Amcal children's paracetamol elixir for 1 to 5 years (batch numbers FA4329 [expiry date 06/2016] and FA4403 [expiry date 07/2016])
  • two batches of Amcal children's paracetamol suspension for 6 to 12 years (batch numbers FA4306 [expiry date 05/2016] and FA4423 [expiry date 08/2016])
  • three batches of Amcal ibuprofen suspension for children (batch numbers IA50251 [expiry date 08/2017], IA50252 [expiry date 08/2017] and IA50705 [expiry date 11/2017])
  • one batch of Amcal cetirizine oral solution for 1 to 12 years (batch number IA50736 [expiry date 05/2018]).

Each of these products is supplied in a 200 ml bottle.

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.

Amcal Children's Paracetamol Elixir for 1 to 5 years Amcal Children's Paracetamol Suspension for 6 to 12 years Amcal Ibuprofen Suspension for Children Amcal Cetirizine 1 - 12 years

Bottles of Amcal children's paracetamol elixir for 1 to 5 years, Amcal children's paracetamol suspension for 6 to 12 years, Amcal ibuprofen suspension for children, and Amcal cetirizine oral solution for 1 to 12 years.

Paracetamol and ibuprofen are used to relieve pain and fever. Ibuprofen can also be used to reduce inflammation.

Cetirizine is an antihistamine used primarily to treat hay fever and hives.

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

Information for consumers

If you or someone you care for is using Amcal children's paracetamol elixir for 1 to 5 years, Amcal children's paracetamol suspension for 6 to 12 years, Amcal ibuprofen suspension for children, or Amcal cetirizine oral solution for 1 to 12 years, please be aware of this issue and check the batch number (displayed on the side of the carton and on the bottle label).

If you have a bottle with a batch number listed above, 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 Amcal children's paracetamol elixir for 1 to 5 years, Amcal children's paracetamol suspension for 6 to 12 years, Amcal ibuprofen suspension for children, or Amcal cetirizine oral solution for 1 to 12 years, advise them or their carers of this issue.

If they have a bottle with a batch number listed above, 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.