Acurenal

Q: Is this product safe to consume?

No. This product has been recalled due to: 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.

Q: Which batches are affected?

Affected batch numbers: 80212781

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

EAN Code

05909991125516

Recall Date

24.04.2025

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.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: 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.

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: 80212781

Acurenal

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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