Tabex

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

suspected failure to meet quality requirements regarding the impurity content parameter – for N-formylcytisine impurity, which may pose a potential risk to patients’ health or life. Potential effects: adverse reactions, possible poisoning or other health complications.

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Risk Level

High

Manufacturer

Sopharma Warszawa sp. z o.o.

Batch Number

41120

Notice Date

05.01.2022

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 Tabex tablets from batches 41120 and 10521. Check the batch number on the packaging and return the product to a pharmacy; consult a doctor if any worrying symptoms occur.

Actions Taken

The Chief Pharmaceutical Inspector withdrew Tabex batches 41120 and 10521 from the market throughout Poland and granted the decision immediate enforceability, obliging the marketing authorisation hold...

Need Help?

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

Tabex

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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