Sigma—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

PRA number

2015/14990

Published date

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.
Amcal 4
Identifying 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]).

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]).

Why the product is recalled

There is a risk of the bottle grooves breaking off when opening the bottle.

What the hazards are 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.

Supplier

Sigma

Where the product was sold

Nationally

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category

Pharmacy