FOSIDAL O SMAKU POMARAŃCZOWYM

Q: Is this product safe to consume?

No. This product has been recalled due to: 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.

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.

Recall Date

11.02.2019

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.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: 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.

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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