Teikoplanina BRADEX
GIF decision: Marketing suspension
What does this decision mean?
- • Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.
Tests by the National Medicines Institute showed failure to meet specification requirements for subvisible particulate contamination (negative result for particles ≥10 μm) and non-compliance of the reconstituted solution appearance with the registration dossier. Potential effects: complications after intravenous administration, local reactions, risk to treatment safety.
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