Soliris

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

Incorrect vial labeling was found – the phrases “concentrate for solution for infusion”, “for intravenous use”, “dilute before use” were in Slovak and Czech, which may hinder correct administration and a risk to health cannot be excluded. Potential effects: serious administration errors, lack of efficacy or treatment complications.

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Risk Level

High

Manufacturer

Alexion Europe SAS z siedzibą we Francji

Batch Number

1004497

Notice Date

28.03.2025

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 product from batch 1004497. Healthcare institutions and pharmacies should immediately withdraw this batch from use and return it to the wholesaler or marketing authorisation holder; in case...

Actions Taken

The Soliris batch 1004497 was withdrawn from the market throughout the country and its placing on the market was prohibited; the decision was given immediate enforceability.

Need Help?

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

Soliris

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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