Sunitinib Vipharm

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

The product does not meet its specified quality requirements due to a negative test result for the appearance parameter; the changed appearance of the capsule filling has not yet been approved in the quality specification. Potential effects: possible concern about medicine quality and a potential risk of dose non-uniformity.

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Risk Level

Low

Manufacturer

Vipharm S.A. z siedzibą w Ożarowie Mazowieckim

Batch Number

wszystkie serie (m.in. 4TX01A)

Notice Date

05.06.2025

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 any batch. Patients who have this medicine should consult their doctor or pharmacist to determine further treatment and possible replacement of the pack.

Actions Taken

Marketing of the medicinal product Sunitinib Vipharm, 25 mg, hard capsules, was suspended throughout the country for all batches and the decision was given immediate enforceability.

Need Help?

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

Sunitinib Vipharm

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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