Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Co-amoxiclav 125 mg／31.25 mg／5 ml and 250 mg／62.5 mg／5 ml Powder for Oral Suspension |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Sandoz Ltd. is recalling 2 lots of Co-amoxiclav 125 mg/31.25 mg/5 ml Powder for Oral Suspension and Co-amoxiclav 250 mg/62.5 mg/5 ml Powder for Oral Suspension. The affected lots are:
- Batch number: HT6202; Expiry date: Feb 2021; Pack size: 100 ml
- Batch number: HT7923; Expiry date: Feb 2021; Pack size: 100 ml
Sandoz Ltd. have been notified of a potential packaging problem relating to poor seal adherence which could cause clumping of the powder within the bottle. A poor bottle seal could lead to degradation of the clavulanic acid within the powder and could potentially render the product ineffective.
This recall is a precautionary measure. No complaints or adverse events relating to this defect have been received by the company from the UK market.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-co-amoxiclav-125-mg-31-25-mg-5-ml-and-25-mg-62-5-mg-5-ml-powder-for-oral-suspension-mdr-24-05-19
In Hong Kong, Curam Powder For Oral Susp 156.25mg/5ml (HK-43478) and Curam Powder For Oral Susp 312.5mg/5ml (HK-43479) are pharmaceutical products containing amoxicillin and clavulanic acid which are manufactured by Sandoz. These products are registered by Novartis Pharmaceuticals (HK) Limited (Novartis), and are prescription-only medicines. As confirmed by Novartis, the affected batches have not been imported into Hong Kong.
Ends/Tuesday, May 14, 2019
Issued at HKT 16:00
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