Product description
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.
See a list of details to help identify the product
Reason the product is recalled
There is a risk of the bottle grooves breaking off when opening the bottle.
The hazards to consumers
If the defect occurs, this poses a potential choking hazard for young children.
What consumers should do
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.
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.
Details to help identify the product
Supplier running the recall
Sigma
Identifying product features
•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]).
Identifying numbers
Other identifying numbers
•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]).
•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]).
Where the product was sold
Nationally
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2015/14990 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.