Fingolimod Stada

GIF decision: Withdrawal from market, Marketing prohibition

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

Stability studies showed an active substance content lower than required, which, according to the Chief Pharmaceutical Inspector, poses a real risk to patients’ health due to the lack of the intended efficacy of the medicinal product. Potential effects: lack of treatment efficacy and possible worsening of the disease.

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Risk Level

High

Manufacturer

STADA Arzneimittel AG z siedzibą w Bad Vilbel, Niemcy

Batch Number

5B0350J

Notice Date

07.08.2025

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 batch 5B0350J, check the batch number of any pack you have and, if it matches, return the medicine to the pharmacy. Patients who have used the medicine from this batch shou...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 5B0350J of the medicinal product Fingolimod Stada from the market throughout the country and prohibited this batch from being placed on the market, gr...

Need Help?

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

Fingolimod Stada

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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