Acurenal

GIF decision: Re-authorization for marketing

What does this decision mean?

• Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

In stability testing for the “impurity A content” parameter, an out-of-specification (OOS) result was obtained relative to the original specification, requiring a change of the limit in the product quality specification, although it was assessed not to pose a risk to patients. Potential effects: no significant health effects; the product remains effective and safe.

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Risk Level

Low

Manufacturer

Bausch Health Ireland Limited z siedzibą w Irlandii

Batch Number

80212781

Notice Date

24.04.2025

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

Patients may continue to use the product as prescribed by their doctor; no additional actions are required from users beyond standard checking of batch number and expiry date.

Actions Taken

The Chief Pharmaceutical Inspector determined the expiry of Decision No. 14/WS/2024 suspending the marketing of the specified batches; previously, the withdrawal procedure was suspended after evidence...

Need Help?

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

Acurenal

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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