FOSIDAL O SMAKU POMARAŃCZOWYM

Q: Is this product safe to consume?

No. This product has been recalled due to: 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.

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.

Recall Date

11.02.2019

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.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: 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.

What should I do if I already bought this?

Stop using the product immediately. Return it to the store for a full refund. If you consumed it and feel unwell, contact your doctor.

Which batches are affected?

Check the official report for specific batch details.

FOSIDAL O SMAKU POMARAŃCZOWYM

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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