Fluorouracil 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.

Contaminants were detected in vials of batch P2108035, indicating possible non-compliance with quality requirements and a potential risk to patients’ health. Potential effects: treatment complications, infections, lack of therapeutic efficacy.

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Risk Level

Critical

Manufacturer

Accord Healthcare Polska Sp. z o.o.

Batch Number

P2108035

Notice Date

14.10.2022

What to do if you have this product?

A recall means the product may be unsafe. Here is what to do if you have it at home.

1

Do not eat or use the product

Stop using or consuming it immediately and keep it out of reach of children.
2

Check the batch number and expiry date

Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.
3

Return it to the shop

You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.
4

Get help and report it

If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.

General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.

Important Information

What You Should Know

Recommendations

Do not use Fluorouracil Accord from batch P2108035; if you have this product, return it to the pharmacy/hospital and consult a doctor if in doubt.

Actions Taken

The medicinal product Fluorouracil Accord batch P2108035 was suspended from the market nationwide, the decision was given immediate enforceability, and the company was obliged to take actions in accor...

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

Fluorouracil Accord

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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