Mebelin

Q: Is this product safe to consume?

No. This product has been recalled due to: Tests by the National Medicines Institute showed that the product does not meet the quality specification for mebeverine hydrochloride release – release after 2, 8 and 12 hours was below the lower acceptance limit, affecting the product’s effectiveness. Potential effects: lack or reduction of therapeutic efficacy, possible worsening of disease symptoms.

Q: Which batches are affected?

Affected batch numbers: EMBCD1002A, wszystkie serie

Tests by the National Medicines Institute showed that the product does not meet the quality specification for mebeverine hydrochloride release – release after 2, 8 and 12 hours was below the lower acceptance limit, affecting the product’s effectiveness. Potential effects: lack or reduction of therapeutic efficacy, possible worsening of disease symptoms.

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Risk Level

Medium

Manufacturer

Aristo Pharma sp. z o.o., z siedzibą w Warszawie

Batch Number

EMBCD1002A, wszystkie serie

EAN Code

05909991425289

Recall Date

30.10.2023

What You Should Know

Recommendations

Do not use the product with GTIN 05909991425289 and 05909991425296; patients who have this medicine should consult a doctor or pharmacist to obtain suitable alternative therapy.

Actions Taken

Following the negative quality test results from the National Medicines Institute and a prior suspension of distribution, the Chief Pharmaceutical Inspector issued a decision banning the placing on th...

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: Tests by the National Medicines Institute showed that the product does not meet the quality specification for mebeverine hydrochloride release – release after 2, 8 and 12 hours was below the lower acceptance limit, affecting the product’s effectiveness. Potential effects: lack or reduction of therapeutic efficacy, possible worsening of disease symptoms.

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: EMBCD1002A, wszystkie serie

Mebelin

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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