Vectibix

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 quality defect could cause leakage and loss of sterility of the medicine, creating a risk of microbial contamination and serious adverse reactions, posing a threat to the patient’s health and life. Potential effects: infection, severe complications, sepsis, life-threatening conditions.

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Risk Level

Critical

Manufacturer

Amgen Europe B.V. Holandia

Batch Number

1151414A

Notice Date

05.04.2023

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 the product from batch 1151414A, check the batch number on the packaging, return the medicine to the pharmacy or the marketing authorisation holder; if the product has been used, contact a ...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 1151414A of Vectibix 20 mg/ml, concentrate for solution for infusion, from the market nationwide, granted the decision immediate enforceability, and o...

Need Help?

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

Vectibix

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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