Oxydolor

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Stability studies of the product batches showed an out-of-specification result for active substance content, which may lead to incorrect dosing of the medicine. Potential effects: lack of treatment efficacy or overdose, complications, risk to health.

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Risk Level

High

Manufacturer

G.L.Pharma GmbH, Austria

Batch Number

9F119A, 9F119B

Notice Date

28.08.2020

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 batches 9F119A and 9F119B; if you have it, return the medicine to a pharmacy or consult a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batches 9F119A and 9F119B of Oxydolor 40 mg prolonged-release tablets from the market nationwide 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.

Oxydolor

What to do if you have this product?

What You Should Know

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Actions Taken

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