Elofen

Q: Is this product safe to consume?

No. This product has been recalled due to: Determination of a risk of use disproportionate to the therapeutic effect of the medicinal product Elofen, with a significant probability of harm to individuals and a real, highly probable threat to patients’ health or life. Potential effects: serious adverse reactions, complications, threat to health or life, lack of a favorable benefit‑risk balance.

Q: Which batches are affected?

Affected batch numbers: wszystkie serie

Determination of a risk of use disproportionate to the therapeutic effect of the medicinal product Elofen, with a significant probability of harm to individuals and a real, highly probable threat to patients’ health or life. Potential effects: serious adverse reactions, complications, threat to health or life, lack of a favorable benefit‑risk balance.

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Risk Level

Critical

Manufacturer

Polfarmex S.A.

Batch Number

wszystkie serie

Recall Date

22.08.2019

What You Should Know

Recommendations

Do not use Elofen syrup from any batch. Patients should consult a physician to choose an alternative therapy and, in case of doubts or adverse symptoms, urgently contact a doctor.

Actions Taken

Temporarily prohibited placing all Elofen batches on the market and suspended their distribution, then revoked the marketing authorization and issued a decision to withdraw the product from the market...

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: Determination of a risk of use disproportionate to the therapeutic effect of the medicinal product Elofen, with a significant probability of harm to individuals and a real, highly probable threat to patients’ health or life. Potential effects: serious adverse reactions, complications, threat to health or life, lack of a favorable benefit‑risk balance.

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?

Affected batch numbers: wszystkie serie

Elofen

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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