FOSIDAL O SMAKU POMARAŃCZOWYM

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

An unfavorable benefit-risk ratio was identified for the active substance fenspiride, posing a potential threat to patients’ health or life, justifying immediate suspension of marketing and a temporary ban on placing the product on the market. Potential effects: serious adverse reactions, threat to health or life.

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Risk Level

Critical

Manufacturer

Medana Pharma S.A.

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 Fosidal orange flavour from any batch; patients should consult a physician regarding further treatment and, if possible, return the product to the pharmacy.

Actions Taken

A decision was issued imposing a temporary ban on placing on the market and suspending the marketing of all batches of Fosidal orange flavour, with immediate enforceability.

Need Help?

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

FOSIDAL O SMAKU POMARAŃCZOWYM

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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