PULNEO

Q: Is this product safe to consume?

No. This product has been recalled due to: It was found that, based on new non-clinical studies, the benefit-risk ratio for the active substance fenspiride is not favorable, which may pose a real and highly probable threat to patients’ health or life. Potential effects: serious adverse reactions, complications, risk to health or life.

It was found that, based on new non-clinical studies, the benefit-risk ratio for the active substance fenspiride is not favorable, which may pose a real and highly probable threat to patients’ health or life. Potential effects: serious adverse reactions, complications, risk to health or life.

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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. Check the product name and, if you have this medicine, stop using it and consult a doctor regarding further treatment.

Actions Taken

A decision was issued to temporarily prohibit placing Pulneo on the market and to suspend the marketing of all its batches, 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: It was found that, based on new non-clinical studies, the benefit-risk ratio for the active substance fenspiride is not favorable, which may pose a real and highly probable threat to patients’ health or life. Potential effects: serious adverse reactions, complications, risk 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.

PULNEO

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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