Clarithromycin Adamed

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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.

Falsification of the active substance Clarithromycin and lack of confirmation that quality requirements for the key component of this parenteral product (solution for infusion) are met have been identified, so a risk to patients' health or life cannot be excluded. Potential effects: lack of treatment efficacy, unpredictable adverse reactions, severe life-threatening complications.

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