Seronil

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 non-compliance in the level of N-nitroso fluoxetine impurity indicates a loss of the medicine’s quality, and the established acceptance criterion was exceeded, so a risk to human health cannot be excluded. Potential effects: increased risk of toxic effects, complications and altered treatment efficacy.

Download the app and stay informed

Get instant notifications about recalled products and protect your family.

App Store Google Play

Risk Level

High

Manufacturer

Orion Corporation

Batch Number

2229543

Notice Date

25.06.2025

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 the medicine from the specified batches. Check the batch number on the packaging and, if you have products from these batches, return them to the pharmacy. In case of any doubts, consult a ...

Actions Taken

Withdrawal from the market throughout the country of two batches of Seronil 20 mg hard capsules, prohibition of placing these batches on the market, and granting the decision immediate enforceability.

Need Help?

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

Seronil

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

Other Notices

Teicoplanin AptaPharma

Teicoplanin AptaPharma

Azaneson

Imuldosa

Loperamid APTEO MED