Mivacron

GIF decision: Withdrawal from market, Marketing prohibition

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

The presence of glass particles in ampoules of an intravenously administered medicine cannot be excluded, which may cause direct negative health consequences for patients, including vascular damage and embolic events. Potential effects: vessel damage, thromboembolic complications, acute reactions, life‑threatening events.

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Risk Level

Critical

Manufacturer

Aspen Pharma Trading Ltd.

Batch Number

XP1TC

Notice Date

24.10.2025

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 batches XP1TC, XPC2W and XPC22. Healthcare institutions should immediately withdraw these batches from use and return them to the wholesaler. If a patient has received medicine...

Actions Taken

Batch XP1TC was withdrawn from the national market and batches XP1TC, XPC2W and XPC22 of Mivacron were prohibited from being placed on the market. The decision was given immediate enforceability, and ...

Need Help?

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

Mivacron

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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