Egoropal

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

The medicinal product does not meet quality requirements due to a negative test result for the particle size analysis parameter in the prolonged-release suspension for injection. Potential effects: abnormal dose release, reduced efficacy or increased risk of adverse reactions.

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Risk Level

Critical

Manufacturer

Egis Pharmaceuticals PLC z siedzibą w Budapeszcie, Węgry

Batch Number

4201475

Notice Date

08.05.2024

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 the product from batch 4201475, check the batch number on the packaging and return any packs held to a pharmacy; if the product has been used, consult a doctor.

Actions Taken

Withdrawal of batch 4201475 of Egoropal from the market throughout the country and a ban on placing this batch on the market, with the decision given immediate enforceability.

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

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Actions Taken

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