Egoropal

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.

A routine FDA inspection revealed serious deficiencies in aseptic manufacturing processes; the assessed risk to product quality and patient safety for aseptically filled batches on the market is high. The product is a parenteral solution for injection. Potential effects: infections after parenteral administration, severe complications, lack of treatment safety.

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