Levosimendan Kabi

Q: Is this product safe to consume?

No. This product has been recalled due to: 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.

Q: Which batches are affected?

Affected batch numbers: wszystkie serie (m.in. 20842750)

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.

Download the app and stay informed

Get instant notifications about recalled products and protect your family.

App Store Google Play

Risk Level

Critical

Manufacturer

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

Batch Number

wszystkie serie (m.in. 20842750)

EAN Code

05909991485894, 05909991485917, 05909991485900

Recall Date

04.03.2024

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.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: 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.

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 (m.in. 20842750)

Levosimendan Kabi

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

Other Recalled Products

Lorafen

Carmustine Accord

Taromentin

Plerixafor MSN

Zoledronic Acid Noridem