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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Unidentified solid particles were detected in the solution for infusion; due to the unknown nature of the contamination, a risk to patients’ health and life cannot be excluded. Potential effects: thrombotic complications, emboli, 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

TREP0605

Notice Date

24.07.2023

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 product from batch TREP0605, check the batch number on the packaging, return the product to the pharmacy or place of purchase, and if the product has been used, contact a doctor.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch TREP0605 of Tresuvi from the market throughout the country and granted the decision immediate enforceability; the marketing authorisation holder was o...

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

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Actions Taken

Need Help?

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