Acurenal

Q: Is this product safe to consume?

No. This product has been recalled due to: suspected non-compliance with the specification for the parameter "impurity A content" in stability studies, including an OOS result for batch 80212781; after limit extension and toxicological assessment, no risk to the patient was confirmed. Potential effects: no or minimal health risk; the product remains effective.

Q: Which batches are affected?

Affected batch numbers: 80219782

suspected non-compliance with the specification for the parameter "impurity A content" in stability studies, including an OOS result for batch 80212781; after limit extension and toxicological assessment, no risk to the patient was confirmed. Potential effects: no or minimal health risk; the product remains effective.

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Risk Level

Low

Manufacturer

Bausch Health Ireland Limited z siedzibą w Irlandii

Batch Number

80219782

EAN Code

05909991125615

Recall Date

24.04.2025

What You Should Know

Recommendations

Patients may continue to use the product as prescribed; there is no need to return the specified batches. In case of doubt, they should contact their doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector declared the expiry of Decision No. 14/WS/2024 suspending distribution of batches 80219782 and 80212781 after approval of the quality specification change by the Pre...

Need Help?

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

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: suspected non-compliance with the specification for the parameter "impurity A content" in stability studies, including an OOS result for batch 80212781; after limit extension and toxicological assessment, no risk to the patient was confirmed. Potential effects: no or minimal health risk; the product remains effective.

What should I do if I already bought this?

Stop using the product immediately. Return it to the store for a full refund. If you consumed it and feel unwell, contact your doctor.

Which batches are affected?

Affected batch numbers: 80219782

Acurenal

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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