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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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

It was found that in batches 2127580 and 2132779 the level of the impurity N-nitroso fluoxetine exceeds the temporary limit acceptable to EMA, which means loss of the required quality of the medicine and a potential risk to human health. Potential effects: possible carcinogenic effects with long-term use, impaired treatment efficacy.

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Risk Level

High

Manufacturer

Orion Corporation

Batch Number

2127580

Notice Date

14.08.2025

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 Seronil 20 mg from batches 2127580 and 2132779. Check the batch number on the packaging; if you possess these batches, return the product to a pharmacy and consult your doctor or pharmacist...

Actions Taken

The Chief Pharmaceutical Inspector withdrew Seronil 20 mg hard capsules batches 2127580 and 2132779 from the entire national market, prohibited their placing on the market, and granted the decision im...

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?

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