Egoropal

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

A routine FDA inspection revealed serious deficiencies in aseptic manufacturing processes; the assessed risk to product quality and patient safety for aseptically filled batches on the market is high. The product is a parenteral solution for injection. Potential effects: infections after parenteral administration, severe complications, lack of treatment safety.

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Risk Level

Critical

Manufacturer

Egis Pharmaceuticals PLC z siedzibą w Budapeszcie, Węgry

Batch Number

4400718, 4500766, 4501274, 4400293, 4400851, 4500598, 4500832, 4500892, 4501060, 4501376

Notice Date

23.12.2025

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

Stop using the product immediately and return it to the store for a refund.

Actions Taken

The marketing of the specified batches of Egoropal 75 mg and 150 mg has been suspended throughout the country. The decision was given immediate enforceability. The marketing authorisation holder block...

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

Egoropal

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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