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Publication #7855
Reference
Drug alert 14/2023
Name
Drug alert class 4 – 14 2023 – Class 4 medicines defect information – caution in use - Sandoz Ltd - Co-amoxiclav 125/31.25mg/5ml 250/62.5mg/5ml powder for oral suspension
Categories
Scottish Government
Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS
SCOTLAND
DRUGS
SAFETY
RISKS
PHARMACEUTICAL INDUSTRY
MEDICINES RECAL
Description
Sandoz limited has informed the MHRA that the products mentioned in this notification are not sugar free despite the carton stating ‘sugar free’. The ‘sugar free’ text was added to the carton in December 2008 in error. All batches supplied since December 2008 have contained a very small quantity of sugar originating from the flavouring. The contained sugars are dextrose and maltodextrin, which are both composed of glucose. However, for a small cohort of patients the product may not be suitable. The maximum daily intake of sugar from Co-Amoxiclav powder for oral solution is equivalent to less than 1% of the maximum daily intake recommended by the World Health Organisation (WHO). The total amount of sugar at the maximum daily doses equates to 204.3 mg in children, 127.8 mg in adults, based on dosing recommendations as per the Summary of Product Characteristics (SmPC).
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2023-04-20 00:00:00
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