
AI-generated summary
Fluorouracil Accord is an anticancer medicine used to treat cancer patients, administered intravenously as a solution for injection or infusion.
The decision concerns Fluorouracil Accord (Fluorouracilum) at a concentration of 50 mg/ml, in the form of a solution for injection or infusion, in packs of one 20 ml vial (GTIN 05909990774791). The trading suspension covers the following series:
- P2403768 – expiry date: 09/2026
- H2500329 – expiry date: 09/2026
- G2500676 – expiry date: 11/2026
All mentioned batches are to be withdrawn from the market and destroyed.
What was detected in the medicine?
According to GIF, the reason for the suspension of trade is failure to meet the quality requirements specified in the product specification. A single, unknown contaminant was found in the tested batches in amounts exceeding the permissible limits. Until this contamination is fully identified, a risk to patients' health cannot be ruled out.
"Failure to meet the requirements for this parameter is directly related to the quality of the product and does not allow confirming the safety of further use of the batches covered by the decision. In a situation where the identification of the contamination has not been completed, a full risk assessment is not possible, therefore a risk to human health resulting from leaving these batches on the market cannot be ruled out," emphasizes GIF in the official announcement.
The drug is administered intravenously to cancer patients
The GIF made the decision immediately enforceable. This means that all mentioned batches of the drug must be immediately withdrawn from the market and destroyed. Patients who have doubts about the medicine they are taking should consult their doctor.
AI outlook — possibilities, not facts
Full identification of the contamination will be completed in the coming weeks
Likely · Within weeks
The decision to suspend marketing may be extended to other batches of the drug if a similar contamination is detected
Possible · Within weeks

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