Oxylaxon

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

In this case, the failure of the medicinal products to meet their established quality requirement manifests as an excessively high content of one of the two active substances, i.e. oxycodone hydrochloride. Potential effects: risk of opioid overdose, increased adverse reactions, respiratory complications.

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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 batches covered by the decision; check the batch number on the packaging. If you possess a product from these batches, return it to the pharmacy or consult a doctor.

Actions Taken

Withdrawal from the market throughout the country of the specified Oxylaxon batches and a ban on placing on the market all batches manufactured from granulate batch No. EE03807; the decision was given...

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

Recommendations

Actions Taken

Need Help?

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