Champix

Q: Is this product safe to consume?

No. This product has been recalled due to: 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.

Q: Which batches are affected?

Affected batch numbers: 00019978

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

EAN Code

05909990621262

Recall Date

07.07.2021

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.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: 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.

What should I do if I already bought this?

Stop using the product immediately. Return it to the store for a full refund. If you consumed it and feel unwell, contact your doctor.

Which batches are affected?

Affected batch numbers: 00019978

Champix

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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