Viantan
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.
After reconstitution of the powder, a large fragment of glass was observed inside the vial from one batch of the product. There is a justified suspicion of contamination of the infusion medicinal product with a foreign body. Potential effects: serious complications after intravenous administration, including vascular damage, embolism and life-threatening events.
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