FENSPOGAL

GIF decision: Withdrawal from market

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

A risk of use disproportionate to the therapeutic effect was identified for products containing fenspiride, considered by PRAC and CMDh significant enough to recommend withdrawal of marketing authorizations. Potential effects: serious adverse reactions, risk to health or life, unacceptable safety profile.

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Risk Level

Critical

Manufacturer

Farmaceutyczna Spółdzielnia Pracy Galena

Batch Number

wszystkie serie

Notice Date

22.08.2019

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 this medicinal product. Patients should consult a doctor for alternative treatment and check whether the medicine they possess is Fenspogal 2 mg/ml syrup.

Actions Taken

Temporary suspension and prohibition of placing all batches on the market, followed by withdrawal of Fenspogal from the market throughout the country after withdrawal of its marketing authorization, w...

Need Help?

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

FENSPOGAL

What to do if you have this product?

What You Should Know

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Actions Taken

Need Help?

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