Ulipristal Acetate Gedeon Richter

Q: Is this product safe to consume?

No. This product has been recalled due to: The PRAC Committee recorded a new case of severe liver injury after the use of ulipristal 5 mg, which required a liver transplant; the existing risk minimisation measures were deemed insufficient. Potential effects: severe liver damage, liver failure, life-threatening condition.

Q: Which batches are affected?

Affected batch numbers: wszystkie serie

The PRAC Committee recorded a new case of severe liver injury after the use of ulipristal 5 mg, which required a liver transplant; the existing risk minimisation measures were deemed insufficient. Potential effects: severe liver damage, liver failure, life-threatening condition.

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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 Ulipristal Acetate Gedeon Richter, check any packs you have and, if you possess them, consult a doctor to choose an alternative treatment.

Actions Taken

The Chief Pharmaceutical Inspector suspended the marketing of all batches of the product throughout the country and granted the decision immediate enforceability; the marketing authorisation holder mu...

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: The PRAC Committee recorded a new case of severe liver injury after the use of ulipristal 5 mg, which required a liver transplant; the existing risk minimisation measures were deemed insufficient. Potential effects: severe liver damage, liver failure, life-threatening condition.

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

Ulipristal Acetate Gedeon Richter

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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