Carmustine Accord

GIF decision: Marketing suspension

What does this decision mean?

  • Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

The solvent component of the medicine does not meet quality requirements due to a negative test result for the "residue on evaporation" parameter, with a value several times above the acceptable limit. Potential effects: poisoning, toxic effects, complications after intravenous administration.

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Carmustine Accord
Risk Level
Critical
Manufacturer
Accord Healthcare Polska Sp. z o.o.
Batch Number
M2407509, M2407512
Notice Date
23.12.2025
View official statement

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