Syntarpen

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 risk of microbiological contamination has been identified in batch 2031025 of this parenteral product (powder for solution for injection), which may lead to increased risk to patient health and inadequate medicinal product quality. Potential effects: infections, sepsis, serious complications, lack of treatment efficacy.

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