VALZEK

GIF decision: Re-authorization for marketing

What does this decision mean?

• Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

Suspected exceedance of acceptable levels of NDMA and NDEA impurities in the active substance Valsartanum from the supplier Zhejiang Tianyu Pharmaceuticals; subsequent tests did not confirm limit exceedances. Potential effects: possible carcinogenic effects with long-term exposure.

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Risk Level

Medium

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

Patients may continue to use Valzek 160 mg as prescribed; if in doubt, they should consult their doctor or pharmacist.

Actions Taken

Initially, all batches of Valzek 160 mg containing active substance from Zhejiang Tianyu Pharmaceuticals were suspended from the market (decision No. 49/WS/2018), and subsequently, after demonstrating...

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

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Actions Taken

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