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Publication #7357
Reference
Drug alert 18/2021
Name
Drug alert class 4 - 18 2021 – Class 4 medicines defect information – caution in use – Brown & Burk UK Limited - Amoxicillin 500 mg/ 5 ml 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
DRUG THERAPY
PHARMACEUTICAL SERVICES
Description
Brown & Burk UK Limited would like to notify of an error regarding specific batches of Amoxicillin 500 mg/ 5 ml Powder for oral suspension, sold and distributed in the UK. The product information incorrectly states the quantity of the excipient sodium benzoate. The actual quantity of sodium benzoate is 3.75mg/5ml. On the PIL it is incorrectly reported as 7.5mg/5ml and in the SmPC it is 15mg/5ml (1.5mg/ml).
Contact Name
Contact Email
Contact Address
Chief Medical Officer Directorate Pharmacy and Medicines Division St Andrew’s House Regent Road Edinburgh EH1 3DG
Contact Phone
Created
2021-07-19 00:00:00
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