Cytostin

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.

In the medicinal product in the form of a solution for injection, visible crystals of unidentified origin were found, probably formed by crystallization of the active substance, which may result in an incorrect dose content and the crystals entering the patient’s bloodstream. Potential effects: cytostatic poisoning, lack of efficacy or thromboembolic complications.

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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 Cytostin from batch I23H024A; pharmacies and wholesalers should immediately withdraw it from use and return it to the supplier. If a product from this batch has been administered, the patie...

Actions Taken

The Chief Pharmaceutical Inspector withdrew Cytostin batch I23H024A from the market nationwide and prohibited its placing on the market, granting the decision immediate enforceability. The wholesaler ...

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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