Sandoz Australia, in consultation with the TGA, is recalling two batches of Curam Duo 400/57
The affected batch numbers are JC5418 and JC5419, both with expiry date July 2021.
The powder for oral suspension (60mL liquid when mixed) is used to treat a wide range of infections caused by bacteria in adults and children and contains amoxicillin as well as potassium clavulanate.
“It has been identified that an anomaly during the manufacture of the affected batches may result in a failure of the air-tight sealing system,” the TGA said.
“This could lead to moisture from the atmosphere entering the product, which could potentially degrade the active ingredients and result in reduced effectiveness.
“If this occurs, it could lead to the medicine not working as it otherwise would, combined with a risk of those patients developing antimicrobial resistance.
“The risk for adverse events as a result of this issue is considered to be higher for children being treated with an affected medicine, than for adults.”
As at 22 May 2019, the TGA had not received any reports of adverse events relating to this issue with the medicine.
It advised that no shortage is expected as a result of the action.
It encouraged patients and carers to check the batch number of any Curam Duo 400/57 in their possession and, if the product is among the affected batch numbers, to return it to their pharmacy or Sandoz for a refund.
Health professionals have been asked to advise patients and carers taking the medicine of the issue and ask them to check the batch number.