Clarithromycin hameln

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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

Lack of confirmed quality of the active substance used for batch 25D052 and non-compliance with GMP requirements in the supply chain. The product is a solution for infusion, so potential quality deviations carry an increased risk to patients' health and life. Potential effects: poisoning, lack of efficacy, complications during intravenous therapy.

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