Soliris

GIF decision: Withdrawal from market

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Risk of confusion among medical staff due to information on the route and method of administration being given in Slovak and Czech on the vial. Potencjalne skutki: incorrect administration of the drug, treatment complications, risk to patient health.

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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 medicine from batch 1004497, check the batch number on the packaging, return the product to the pharmacy; if medicine from this batch was used, consult a doctor.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 1004497 of Soliris from the national market and prohibited its placing on the market, granting the decision 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

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Actions Taken

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