PULNEO

Q: Is this product safe to consume?

No. This product has been recalled due to: An unfavorable benefit-risk ratio for the active substance fenspiride, indicating a potential direct threat to patients’ health or life, requiring immediate suspension of marketing and re‑evaluation of treatment safety. Potential effects: serious adverse reactions, threat to health or life, possible treatment complications.

An unfavorable benefit-risk ratio for the active substance fenspiride, indicating a potential direct threat to patients’ health or life, requiring immediate suspension of marketing and re‑evaluation of treatment safety. Potential effects: serious adverse reactions, threat to health or life, possible treatment complications.

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Risk Level

Critical

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.

Recall Date

11.02.2019

What You Should Know

Recommendations

Do not use Pulneo from any batch. Patients currently taking the product should stop using it and consult a doctor to choose an alternative treatment.

Actions Taken

The Chief Pharmaceutical Inspector imposed a temporary ban on placing Pulneo on the market and suspended the marketing of all batches, granting the decision immediate enforceability. The marketing aut...

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 for the active substance fenspiride, indicating a potential direct threat to patients’ health or life, requiring immediate suspension of marketing and re‑evaluation of treatment safety. Potential effects: serious adverse reactions, threat to health or life, possible treatment 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.

PULNEO

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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