VALZEK

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

This risk may be caused by the presence of N-nitrosodimethylamine (NDMA) contamination in the active substance contained in the medicinal product, which may affect human health and life. Potential effects: possible carcinogenic effects and other serious health disorders with long-term exposure.

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Risk Level

Critical

Manufacturer

Celon Pharma S.A.

Notice Date

06.06.2019

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Do not use the product from the withdrawn batches; patients should check the batch of their medicine, return it to the pharmacy, and consult a doctor if they have any doubts or have been using the med...

Actions Taken

The trade of Valzek 80 mg batches was first suspended and then withdrawn from the market, the decision was given immediate enforceability, and the company was obliged to undertake the required actions...

Need Help?

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

VALZEK

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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