Cytostin

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

In the medicinal product in the form of a solution for injection, crystals of unidentified origin were found, creating a real danger of administering an incorrect active substance dose or of crystals entering the patient’s bloodstream. Potential effects: lack of treatment efficacy, serious vascular complications, life‑threatening events.

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Risk Level

Critical

Manufacturer

podmiot odpowiedzialny: Bruck Pharma PVT. LTD z siedzibą w Indiach; podmiot, który uzyskał zgodę na czasowe dopuszczenie do obrotu produktu leczniczego: MEDYK-LEK Panek sp. k., Warszawa ul. Pawła Włodkowica 2C, 03-262 Warszawa

Batch Number

I23H024A

Notice Date

05.02.2024

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 product from batch I23H024A; immediately withdraw and segregate this batch from distribution and use in pharmacies and hospitals. Medical staff should check batch numbers and, if the ba...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch I23H024A of Cytostin from the market nationwide, prohibited placing this batch on the market, granted the decision immediate enforceability, and oblig...

Need Help?

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

Cytostin

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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