Tresuvi

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

The presence of unidentified solid particles was found in the product, and the nature of the contamination and its cause have not been determined. Therefore, a risk to the patient’s health and life cannot be excluded. Potential effects: infusion complications, embolism, inflammatory reactions, life‑threatening events.

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Risk Level

Critical

Manufacturer

Amomed Pharma GmbH, Leopold-Ungar-Platz 2, 1190 Wiedeń, Austria

Batch Number

TREP0741

Notice Date

07.08.2023

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 Tresuvi from batch TREP0741. If you have a product from this batch, return it to the pharmacy or your doctor. If any worrying symptoms occur after using the product, contact a doctor immedi...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch TREP0741 of Tresuvi from the market nationwide and granted the decision immediate enforceability.

Need Help?

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

Tresuvi

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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