Carmustine Accord

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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

The solvent component of the medicine does not meet quality requirements due to multiple exceedances of the residue after evaporation limit. Analyses indicate contamination with non-volatile residue originating from silicone tubing used for product transfer during manufacturing. Potential effects: no assurance of quality and safety of an infusion product, risk of unpredictable adverse reactions.

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