Vabysmo

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Cracked blisters with needles with a transfer filter were identified in product packs, so sterility of the needles and the solution for injection is not ensured; the defect was classified as Class I, potentially life‑threatening or posing a serious health risk. Potential effects: severe intraocular infections, ophthalmic complications, sepsis, life‑threatening condition.

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Risk Level

Critical

Manufacturer

Roche Registration GmbH z siedzibą w Grenzach-Wyhlen, Niemcy

Batch Number

B1542B19

Notice Date

29.08.2024

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

Do not use product from batch B1542B19, check the batch number on the pack and return packs from this batch to the pharmacy. If the product has been administered, the patient should remain under medic...

Actions Taken

Withdrawal of batch B1542B19 of Vabysmo from the market throughout the country, prohibition of placing this batch on the market, and granting the decision immediate enforceability.

Need Help?

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

Vabysmo

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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