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 risk assessment indicated a high risk to product quality and patient safety for aseptically filled batches available on the market. Potential effects: infection, sepsis, serious complications, lack of treatment efficacy.

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