Omnipaque

GIF decision: Withdrawal from market, Marketing prohibition

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

The manufacturer detected metal particles originating from the mold used for 100 ml polypropylene bottles, causing contamination of the solution for injection and adherent/deposited solid particles in the bottles. The defect was assessed as posing a high risk to patients' health and life. Potential effects: parenteral complications, particle embolism, severe reactions, life-threatening events.

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Risk Level

Critical

Manufacturer

GE Healthcare A.S.

Batch Number

17320901, 17374661, 17244048, 17374668

Notice Date

24.03.2026

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.

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