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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Incorrect information in the leaflet was found: swapped dosing instructions for patients with normal and impaired renal function, which may lead to improper dosing of the injection solution and direct, serious health consequences. Potential effects: poisoning, severe bleeding complications, lack of treatment efficacy, 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

LFH0031, LFH0033, LFH0034

Notice Date

29.08.2024

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 Eptifab from batches LFH0031, LFH0033 and LFH0034. Check the batch number on the packaging; if the medicine from these batches has been used, contact a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batches LFH0031, LFH0033 and LFH0034 of Eptifab, 2 mg/ml, solution for injection from the entire Polish market, granted the decision immediate enforceabilit...

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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