05/22/2019 | Press release | Distributed by Public on 05/21/2019 22:50
Consumers and health professionals are advised that Sandoz Australia, in consultation with the TGA, is recallingtwo batches of Curam Duo 400/57 (batch numbers JC5418 and JC5419, both with expiry date July 2021).
Curam Duo is a prescription medicine that contains a type of antibiotic called amoxicillin, as well as a second active ingredient called potassium clavulanate. It is a powder for oral suspension (60 mL liquid when mixed) that is used to treat a wide range of infections caused by bacteria in adults and children.
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. 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.
At the time of writing, the TGA has received no reports of adverse events relating to this issue with these products.
A medicine shortage is not expected as a result of this action.
Information for consumers
If you or someone you provide care for takes Curam Duo 400/57, check the batch number.
If your medicine has batch number JC5418 or JC5419 (both with expiry date July 2021), stop using it immediately and return it to your pharmacy for a refund. Alternatively, you can call Sandoz Australia on 1800 726 369 to arrange the return of the affected product and a refund.
You may need to discuss ongoing treatment with your doctor, particularly if you or your child have not completed the antibiotic course as prescribed.
If you have any further questions or concerns about this issue, talk to your health professional.
Information for health professionals
If you are treating a patient who is taking Curam Duo 400/57, advise them of this issue and to check the batch number of their medicine.
If they have a product with batch number JC5418 or JC5419 (both with expiry date July 2021), advise them to stop using it immediately and return it to their pharmacy for a refund. Alternatively, they can call Sandoz Australia on 1800 726 369 to arrange the return of the affected product and a refund.
If you have any questions or concerns about this issue, contact Sandoz Australia on 1800 726 369
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.