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Publication #5168
Reference
Drug alert 27/2013
Name
Drug alert class 4 no.27: caution in use [B. Braun Melsungen AG: 8.4% w/v Sodium Bicarbonate]
Categories
Scottish Government
Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
DRUGS
SAFETY
RISKS
PHARMACEUTICAL INDUSTRY
DRUG THERAPY
PHARMACEUTICAL SERVICES
Description
B. Braun Melsungen AG have reported that during regular visual inspection of retained samples of Sodium Bicarbonate solutions with bromobutyl stoppers precipitation in solution was observed. The particles have been identified as aluminum salt precipitation. A fluctuation in the bromobutyl stopper quality, resulting in the leaching of aluminum compounds is believed to be the cause of the issue. The above batches have been released to market using bromobutyl stoppers.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Finance,e-Health and Pharmaceuticals Directorate St Andrew’s House, Regent Road, Edinburgh EH1 3DG
Contact Phone
Created
2013-12-05 00:00:00
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