Egoropal

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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.

A routine FDA inspection revealed serious deficiencies in aseptic manufacturing processes. For a prolonged-release suspension for injection, non-compliance at the sterile manufacturing stage may translate into increased risk to patients' health; a risk to life cannot be excluded. Potential effects: infection, poisoning, severe systemic complications, lack of therapeutic efficacy.

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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

08.01.2026

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.

Important Information

What You Should Know

Recommendations

Do not use Egoropal products from the specified batches. If you possess a product from these batches, contact your doctor or pharmacist to determine further steps. Return the product from the recalled...

Actions Taken

The marketing authorisation holder performed a retrospective assessment of the impact of non-compliance on product quality and patient safety and blocked stocks in all warehouses on affected markets. ...

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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