Champix

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

The presence of N-nitroso-varenicline contamination was found in the bulk product batch, with the level of this impurity exceeding the limit set based on ICH M7 guidance. Potential effects: possible carcinogenic effect and other serious adverse reactions.

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Risk Level

Critical

Manufacturer

Pfizer Europe MA EEIG

Batch Number

00019978

Notice Date

07.07.2021

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 product from batch 00019978. Check the batch number of any packs you have and return them to a pharmacy. If in doubt, consult a doctor or pharmacist.

Actions Taken

Withdrawal from the market throughout the country of batch 00019978 of the medicinal product Champix and granting the decision immediate enforceability; the marketing authorisation holder was obliged ...

Need Help?

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

Champix

What to do if you have this product?

What You Should Know

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Actions Taken

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