Egoropal

GIF decision: Withdrawal from market

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

It was found that the product does not meet quality requirements due to a failed particle size analysis in the injectable suspension. Potential effects: possible altered drug release, lack of efficacy or unpredictable 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. Patients who have packs from this batch should contact their doctor or pharmacist to replace the medicine or arrange alternative therapy.

Actions Taken

Withdrawal of Egoropal medicinal product batch 4201475 from the entire national market and prohibition of placing this batch on the market; the decision was 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

Recommendations

Actions Taken

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