Levosimendan Kabi

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Testing by NIL showed that the product does not meet quality specification requirements regarding contamination with particles visible to the naked eye; in 9 of 20 tested vials such particles were found. Potential effects: complications after intravenous infusion, embolism, inflammation, local or systemic reactions.

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Risk Level

Critical

Manufacturer

Fresenius Kabi Polska sp. z o.o. z siedzibą w Warszawie

Batch Number

wszystkie serie (m.in. 20842750)

Notice Date

04.03.2024

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 from any batch. Check the name and dosage form; return any packs held to a pharmacy or according to the marketing authorisation holder’s instructions. If the medicine has been a...

Actions Taken

The Chief Pharmaceutical Inspector withdrew all batches of Levosimendan Kabi 2.5 mg/ml concentrate for solution for infusion from the Polish market and prohibited their placing on the market, granting...

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

Recommendations

Actions Taken

Need Help?

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