EUREFIN

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 ratio for the active substance fenspiride identified from non-clinical studies; an EU review procedure initiated. Potential effects: serious adverse reactions, threat to health or life.

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EUREFIN
Risk Level
Critical
Manufacturer
Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A.
Notice Date
11.02.2019
View official statement
Source: GIF view the official alert

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. 1

    Do not eat or use the product

    Stop using or consuming it immediately and keep it out of reach of children.

  2. 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. 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. 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 it to the pharmacy or the marketing authorisation holder; contact a physician if adverse effects occur.

Actions Taken

Temporary prohibition on placing Eurefin on the market and suspension of distribution of all batches with immediate enforceability; notification of relevant authorities and initiation of the EU review...

Need Help?

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

Related

Other Notices