Levosimendan Kabi

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

Contamination with particles visible to the naked eye was found in the concentrate for solution for infusion, indicating a serious quality non-compliance of the product. Potential effects: thromboembolic and inflammatory complications, vascular damage, severe adverse effects after intravenous administration.

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Risk Level

Critical

Manufacturer

Fresenius Kabi Polska Sp. z o.o. z siedzibą w Warszawi

Batch Number

20842750

Notice Date

12.10.2023

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 the product, especially batch 20842750. Return any packs in possession to a pharmacy. If the product has been administered and any alarming symptoms occur, contact a doctor immediately.

Actions Taken

The marketing of the medicinal product Levosimendan Kabi 2.5 mg/ml, concentrate for solution for infusion, was suspended throughout the country, the decision was given immediate enforceability, and a ...

Need Help?

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

Levosimendan Kabi

What to do if you have this product?

What You Should Know

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Actions Taken

Need Help?

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