Mitomycin C Kyowa

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Due to identified deviations in the manufacturing process of the active substance, it cannot be ensured that the medicinal products made from it meet sterility specification requirements. The authority points to a potential direct threat to patients’ health or life. Potential effects: infection, severe post-injection complications, risk to health or life.

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Risk Level

Critical

Manufacturer

Nordic Pharma s.r.o. Czechy

Batch Number

013AFL02

Notice Date

25.10.2019

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 batches covered by the decision. Check the batch number of any product held; if affected, return it to the pharmacy or consult a physician. In case of doubt or adverse effects, ...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of the medicinal product from the entire national market and granted the decision immediate enforceability; the marketing authorisatio...

Need Help?

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

Mitomycin C Kyowa

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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