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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

A quality defect was identified involving excessively high oxycodone hydrochloride content in certain Oxylaxon prolonged-release tablet batches, caused by abnormal parameters of granulate batch EE03807. Potential effects: opioid overdose, respiratory depression, poisoning.

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Risk Level

Critical

Manufacturer

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

Batch Number

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

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 Oxylaxon from the listed batches, check the batch number on the package, and return any affected packs to the pharmacy; in case of doubt or symptoms of overdose, consult a doctor.

Actions Taken

Withdrawal from the market throughout the country of specified Oxylaxon batches, prohibition of placing on the market all batches manufactured from granulate EE03807, and granting the decision immedia...

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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