Osporil

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

The National Medicines Institute found in this batch of the medicinal product the presence of particles visible to the naked eye in two of twenty tested vials, causing the batch to fail quality requirements for solution appearance. Potential effects: post-infusion complications, inflammatory reactions, embolism by particles, lack of safety during infusion.

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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 medicine from batch ZD033. Patients and healthcare facilities should check the batch number, stop using products from this batch and return them to the pharmacy or wholesaler; if the me...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch ZD033 of Osporil from the market throughout the country and prohibited placing this batch on the market, granting the decision immediate enforceabilit...

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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