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| Australia: Curam Duo 400／57: Recall – potential for reduced effectiveness (English only) |
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Therapeutic Goods Administration (TGA) announces that Sandoz Australia, in consultation with the TGA, is recalling two 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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/curam-duo-40057
In Hong Kong, Curam For Oral Suspension 457mg/5ml (HK-56738) is a pharmaceutical product registered by Novartis Pharmaceuticals (HK) Limited (Novartis), and is a prescription-only medicine. As confirmed by Novartis, the affected batches have not been imported into Hong Kong. Related news on the recall of other Sandoz amoxicillin and clavulanic acid-containing products was previously issued by the UK Medicines and Healthcare products Regulatory Agency, and was posted on the Drug Office website on 14 May 2019.
Ends/Thursday, May 23, 2019
Issued at HKT 15:00
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