Levosimendan Kabi

Q: Is this product safe to consume?

No. This product has been recalled due to: 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.

Q: Which batches are affected?

Affected batch numbers: wszystkie serie (w badaniu: 20842750)

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)

EAN Code

05909991485894, 05909991485917, 05909991485900

Recall Date

04.03.2024

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.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: 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.

What should I do if I already bought this?

Stop using the product immediately. Return it to the store for a full refund. If you consumed it and feel unwell, contact your doctor.

Which batches are affected?

Affected batch numbers: wszystkie serie (w badaniu: 20842750)

Levosimendan Kabi

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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