Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Amoxicillin 500 mg／5 ml Powder for oral suspension |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Brown & Burk UK Limited has noticed an error regarding specific batches of Amoxicillin 500 mg/5 ml Powder for oral suspension (batch number: ASDBV0001, ASDBV0002, ASDBV0003) sold and distributed in the United Kingdom. The product information incorrectly states the quantity of the excipient sodium benzoate. The actual quantity of sodium benzoate is 3.75 mg/5 ml. On the Patient Information Leaflet (PIL) it is incorrectly reported as 7.5 mg/5 ml and in the Summary of Product Characteristics (SmPC) it is 15 mg/5 ml (1.5 mg/ml).
There is no risk to product quality as a result of this issue, therefore the associated batches are not being recalled at this time. These batches were subject to a batch specific variation, assessed by the MHRA and it was considered that the risk associated with the incorrect information was low and therefore no market action considered.
The product information is in the process of being revised to reflect the correct quantity of sodium benzoate and new batches will be only be distributed with the correct information.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-amoxicillin-500-mg-slash-5-ml-powder-for-oral-suspension-pl-25298-slash-0248-el-21-a-slash-18
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Jul 20, 2021
Issued at HKT 14:00
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