Esmya

Q: Is this product safe to consume?

No. This product has been recalled due to: A case of severe liver injury in a patient using ulipristal acetate 5 mg was identified, requiring liver transplantation; there is a real, significant probability of serious harm to health or life. Potential effects: severe liver damage, liver failure, life-threatening complications.

Q: Which batches are affected?

Affected batch numbers: wszystkie serie

A case of severe liver injury in a patient using ulipristal acetate 5 mg was identified, requiring liver transplantation; there is a real, significant probability of serious harm to health or life. Potential effects: severe liver damage, liver failure, life-threatening complications.

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Risk Level

Critical

Manufacturer

Gedeon Richter Plc. Węgry

Batch Number

wszystkie serie

Recall Date

13.03.2020

What You Should Know

Recommendations

Do not use Esmya (ulipristal acetate) 5 mg; patients currently taking it should contact their physician for further management and liver function assessment.

Actions Taken

All batches of the medicinal product Esmya 5 mg were suspended from marketing throughout the country; the decision was given immediate enforceability; the marketing authorisation holder was obliged to...

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 case of severe liver injury in a patient using ulipristal acetate 5 mg was identified, requiring liver transplantation; there is a real, significant probability of serious harm to health or life. Potential effects: severe liver damage, liver failure, life-threatening 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?

Affected batch numbers: wszystkie serie

Esmya

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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