Levosimendan Kabi

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

The product was found to be contaminated with particles visible to the naked eye in 9 of 20 tested vials of the 2.5 mg/ml concentrate for solution for infusion, which means it does not meet quality specification requirements. Potential effects: complications after intravenous administration, emboli, local reactions, lack of therapy safety.

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Risk Level

Critical

Manufacturer

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

Batch Number

wszystkie serie (w badaniu: 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 this medicinal product. Check the GTIN and batch, and return any packs held to the pharmacy or supplier. If the product has been administered, monitor the patient and contact a doctor if an...

Actions Taken

The Chief Pharmaceutical Inspector withdrew all batches of Levosimendan Kabi from the market throughout the country and prohibited their placing on the market, granting the decision immediate enforcea...

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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