XALOPTIC FREE

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Exceeding specification limits for related substances content in several batches of Xaloptic Free and suspected occurrence of the same quality defect in further batches, indicating non‑compliance with quality requirements. Potential effects: lack of treatment efficacy, adverse reactions, therapy complications.

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Risk Level

Medium

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Notice Date

29.03.2019

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Do not use the product from the withdrawn batches, check the batch number on the packaging and, if you have the product, contact a pharmacy or doctor for return and medical advice.

Actions Taken

The Chief Pharmaceutical Inspector decided to withdraw specific batches of the medicinal product Xaloptic Free from the market throughout the country and granted the decision immediate enforceability.

Need Help?

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

XALOPTIC FREE

What to do if you have this product?

What You Should Know

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Actions Taken

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