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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Presence of N-nitrosodimethylamine (NDMA) contamination above the acceptable limit was found in the active substance Valsartan, which may pose a threat to patients' health and life. Potential effects: poisoning, carcinogenic effects, health complications with long-term use.

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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Do not use the medicine from the withdrawn batches, check the batch number on the package, and if you have such a product, contact a pharmacy or doctor to determine further steps.

Actions Taken

The Chief Pharmaceutical Inspector issued a decision to withdraw batches of Valzek 160 mg from the market with immediate enforceability; the marketing authorisation holder was obliged to carry out the...

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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