EURESPAL

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

Unfavourable benefit–risk balance of the active substance fenspiride, which may pose a public health risk. Potential effects: deterioration of health, complications, life‑threatening risk.

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Risk Level

Critical

Manufacturer

Les Laboratoires Servier z siedzibą we Francji

Notice Date

11.02.2019

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; return stocks to the point of sale/pharmacy or the manufacturer; consult a doctor or pharmacist if in doubt; check the batch number.

Actions Taken

Temporary ban on placing the product on the market and suspension of distribution of all batches; MAH reported withdrawal of the product; initiation of an EU procedure to re-evaluate the benefit–risk ...

Need Help?

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

EURESPAL

What to do if you have this product?

What You Should Know

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