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
See a list of details to help identify the product.
Reason 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.
Details to help identify the product.
Supplier running the recall
Sandoz Australia Pty Limited
Who sold the product
Pharmaceutical wholesalers
Pharmacies
Hospital pharmacies
Pharmacies
Hospital pharmacies
Identifying numbers
Barcode number
9322838004953
SKU
980241
Other identifying numbers
Batch Numbers JC5418 and JC5419 only
Dates available for sale
-
Where the product was sold
Nationally
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2019/17570 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.