PRA number
2019/17570
Published date
Product description
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.
Affected batches JC5418 and JC5419 only
Expiry date July 2021
ARTG: AUST R 147109
Affected batches JC5418 and JC5419 only
Expiry date July 2021
ARTG: AUST R 147109
Reasons the product is recalled
During manufacture, the air tight seal in some units may have been compromised. This could allow the entry of moisture from the air.
The hazards to consumers
Over time, this may result in the significant degradation of the active ingredients and the production of related impurities.
This may mean that the product has reduced effectiveness and patients may also be at risk of developing antimicrobial resistance.
The risk of adverse events is considered to be higher for children than for adults.
This may mean that the product has reduced effectiveness and patients may also be at risk of developing antimicrobial resistance.
The risk of adverse events is considered to be higher for children than for adults.
What consumers should do
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.
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.
Supplier
Sandoz Australia Pty Limited
Traders who sold this product
Pharmaceutical wholesalers
Pharmacies
Hospital pharmacies
Pharmacies
Hospital pharmacies
Where the product was sold
Nationally
Dates available for sale
-
Recall advertisements and supporting documentation
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.