Zodgane

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.

Test result out of specification for particle size distribution D(0.9) (batch 1254), indicating suspected failure to meet quality requirements. Potential effects: possible reduced efficacy of the medicine.

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Risk Level

Medium

Manufacturer

Zentiva k.s. z siedzibą w Pradze

Batch Number

1254

Notice Date

08.05.2024

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

Check the batch number (1254) and expiry date; if in doubt consult a doctor or pharmacist.

Actions Taken

The GIF initially suspended nationwide distribution (decision of 30-01-2024 with immediate effect). After repeat testing and a post‑registration change was submitted, the GIF rescinded the contested d...

Need Help?

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

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What to do if you have this product?

What You Should Know

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Actions Taken

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