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Publication #7392
Reference
Drug alert 20/2021
Name
Drug alert class 2 - 20 2021 – Class 2 medicines recall action within 48 hours – caution in use – Rosemont Pharmaceuticals Limited – Metformin Hydrochloride 500mg/ml oral solution
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
Rosemont Pharmaceuticals Limited is recalling all unexpired stock of the above product from pharmacies and wholesalers as a precautionary measure due to the identification level of an impurity above the acceptable limit. Following routine monitoring, the impurity, N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential, has been observed at a level above the acceptable limit.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Chief Medical Officer Directorate Pharmacy and Medicines Division St Andrew’s House Regent Road Edinburgh EH1 3DG
Contact Phone
Created
2021-08-25 00:00:00
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