FENSPOGAL

Q: Is this product safe to consume?

No. This product has been recalled due to: A risk of use disproportionate to the therapeutic effect was identified for products containing fenspiride, considered by PRAC and CMDh significant enough to recommend withdrawal of marketing authorizations. Potential effects: serious adverse reactions, risk to health or life, unacceptable safety profile.

Q: Which batches are affected?

Affected batch numbers: wszystkie serie

A risk of use disproportionate to the therapeutic effect was identified for products containing fenspiride, considered by PRAC and CMDh significant enough to recommend withdrawal of marketing authorizations. Potential effects: serious adverse reactions, risk to health or life, unacceptable safety profile.

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Risk Level

Critical

Manufacturer

Farmaceutyczna Spółdzielnia Pracy Galena

Batch Number

wszystkie serie

Recall Date

22.08.2019

What You Should Know

Recommendations

Do not use this medicinal product. Patients should consult a doctor for alternative treatment and check whether the medicine they possess is Fenspogal 2 mg/ml syrup.

Actions Taken

Temporary suspension and prohibition of placing all batches on the market, followed by withdrawal of Fenspogal from the market throughout the country after withdrawal of its marketing authorization, w...

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: A risk of use disproportionate to the therapeutic effect was identified for products containing fenspiride, considered by PRAC and CMDh significant enough to recommend withdrawal of marketing authorizations. Potential effects: serious adverse reactions, risk to health or life, unacceptable safety profile.

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

FENSPOGAL

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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