FOSIDAL O SMAKU POMARAŃCZOWYM

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  • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

It was found that the risk of using products containing fenspiride is disproportionate to their therapeutic effect, with a potential threat to patients’ health or life. Potential effects: serious adverse reactions, complications and life‑threatening events.

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FOSIDAL O SMAKU POMARAŃCZOWYM
Risk Level
Critical
Manufacturer
Medana Pharma S.A.
Batch Number
wszystkie serie
Notice Date
22.08.2019
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. Check whether your syrup is Fosidal orange flavour 2 mg/ml; if so, stop using it and consult a doctor to select alternative treatment.

Actions Taken

The Chief Pharmaceutical Inspector withdrew all batches of Fosidal orange flavour from the market throughout the country and granted the decision immediate enforceability.

Need Help?

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

Related

Other Notices