FOSIDAL O SMAKU POMARAŃCZOWYM

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.

An unfavourable benefit-risk ratio was identified for the active substance fenspiride, associated with a potential, real and highly probable risk to patients’ health or life, requiring immediate action by supervisory authorities. Potential effects: serious adverse reactions, risk to health or life, possible cardiac complications.

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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 syrup. Patients should consult a physician regarding further treatment and possible replacement of the product with another medicine.

Actions Taken

The Chief Pharmaceutical Inspector, at the request of the President of the Office for Registration, imposed a temporary ban on placing on the market and suspended the distribution of all batches of Fo...

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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