Eptifab

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

An incorrect dosing regimen for the medicinal product in solution for injection form, resulting from erroneous leaflet data, may cause direct adverse health consequences for patients, posing a real risk to health and potentially to life. Potential effects: overdose or insufficient efficacy, serious cardiovascular complications, life‑threatening events.

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Risk Level

Critical

Manufacturer

podmiot odpowiedzialny: Abbott Healthcare Private Limited z siedzibą w Indiach; podmiot, który uzyskał zgody na czasowe wprowadzenie do obrotu produktu leczniczego: Delfarma sp. z o.o. z siedzibą w Łodzi

Batch Number

LFH0032

Notice Date

16.08.2024

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 medicine from batch LFH0032. Patients should check the batch number and, if they have this product, return it to a pharmacy or physician. Individuals who have already received the drug ...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch LFH0032 of Eptifab from the market nationwide, granted the decision immediate enforceability, and obliged the company to promptly carry out withdrawal...

Need Help?

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

Eptifab

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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