Oxylaxon

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Failure of the medicinal products to meet the specified quality requirement manifests as excessively high content of one of the two active substances, oxycodone hydrochloride, which may expose patients to receiving a substandard medicinal product. Potential effects: excessive opioid effect, serious adverse reactions, complications of pain therapy.

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Risk Level

High

Manufacturer

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Batch Number

E02215,F03209,F03210,E02270,F06046,F04680,E05198,E06924,F06611,F10132,F00149,E02249,E02259,F00148,E02261,F04703,F08633

Notice Date

27.11.2023

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 the listed batches; check the batch number on the packaging and, if you have these batches, contact your doctor or pharmacist to determine further treatment and possible re...

Actions Taken

Specified batches of Oxylaxon were withdrawn from the market throughout the country and placing on the market of all batches manufactured from granulate batch EE03807 was prohibited; the decision was ...

Need Help?

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

Oxylaxon

What to do if you have this product?

What You Should Know

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Actions Taken

Need Help?

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