PHELINUN

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 identified discrepancy in the incorrectly described label on the vial with powder may pose a risk of incorrect preparation of the medicine, and thus a health risk to patients cannot be excluded. Potencjalne skutki: lack of treatment efficacy or complications related to an inappropriate dose of cytostatic drug.

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Risk Level

High

Manufacturer

ADIENNE S.r.l. S.U. z siedzibą w Caponago

Batch Number

24P012

Notice Date

11.12.2025

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

Do not use Phelinun from batch 24P012. Check the batch number on the packaging and return the product to the pharmacy or wholesaler. If a medicine from this batch has been administered, contact the tr...

Actions Taken

The Chief Pharmaceutical Inspector withdrew Phelinun batch 24P012 from the market nationwide, prohibited placing this batch on the market and granted the decision immediate enforceability; the marketi...

Need Help?

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

PHELINUN

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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