Osporil

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

The National Medicines Institute found, in batch ZD033, particles visible to the naked eye in two of twenty inspected vials of the infusion solution. Potential effects: embolism, inflammatory reactions, complications after intravenous administration.

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Risk Level

Critical

Manufacturer

Egis Pharmaceuticals PLC z siedzibą w Budapeszcie, Węgry

Batch Number

ZD033

Notice Date

09.01.2025

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 ZD033, check the batch number on the packaging, and if you have this batch, return the product to the pharmacy and, if it has been administered, consult a doctor.

Actions Taken

Withdrawal from the market throughout the country of batch ZD033 of Osporil and a ban on placing this batch on the market, with the decision given immediate enforceability.

Need Help?

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

Osporil

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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