Ebetrexat

GIF decision: Withdrawal from market

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

It was found that the sample did not meet the product specification requirements for purity; the out-of-specification result concerned the parameter "content of related substance impurities". Potential effects: altered drug effect, possible increased adverse reactions or complications of therapy.

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Risk Level

Critical

Manufacturer

Ebewe Pharma Ges.m.b.H Nfg. KG z siedzibą w Austrii

Batch Number

JK5608

Notice Date

10.04.2020

What to do if you have this product?

A recall means the product may be unsafe. Here is what to do if you have it at home.

1

Do not eat or use the product

Stop using or consuming it immediately and keep it out of reach of children.
2

Check the batch number and expiry date

Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.
3

Return it to the shop

You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.
4

Get help and report it

If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.

General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.

Important Information

What You Should Know

Recommendations

Do not use the product from batch JK5608; patients should check the batch number, return the packs to a pharmacy or doctor, and consult a doctor if in doubt.

Actions Taken

Withdrawal from the market throughout the country of batch JK5608 of Ebetrexat 20 mg/ml, solution for injection, and granting the decision immediate enforceability.

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

Ebetrexat

What to do if you have this product?

What You Should Know

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Actions Taken

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