Egoropal

GIF decision: Withdrawal from market, Marketing prohibition

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

A routine FDA inspection revealed serious deficiencies in aseptic manufacturing processes. For a prolonged-release suspension for injection, non-compliance at the sterile manufacturing stage may translate into increased risk to patients' health; a risk to life cannot be excluded. Potential effects: infection, poisoning, severe systemic complications, lack of therapeutic efficacy.

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