BENODIL

Q: Is this product safe to consume?

No. This product has been recalled due to: A quality defect was identified consisting of out-of-specification results for the parameter of budesonide-related substances content, which may indicate an improper impurity profile and lack of compliance with quality requirements. Potential effects: possible reduced treatment efficacy or increased risk of adverse reactions.

A quality defect was identified consisting of out-of-specification results for the parameter of budesonide-related substances content, which may indicate an improper impurity profile and lack of compliance with quality requirements. Potential effects: possible reduced treatment efficacy or increased risk of adverse reactions.

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Risk Level

Medium

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Recall Date

15.03.2019

What You Should Know

Recommendations

Do not use the batches covered by the withdrawal decision; patients should check the batch number of their medicine and, if included in the recall, contact a pharmacy or doctor for replacement or furt...

Actions Taken

The Chief Pharmaceutical Inspector issued a decision to withdraw the specified batches of the medicinal product from the market throughout the country and granted it immediate enforceability; the mark...

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: A quality defect was identified consisting of out-of-specification results for the parameter of budesonide-related substances content, which may indicate an improper impurity profile and lack of compliance with quality requirements. Potential effects: possible reduced treatment efficacy or increased risk of adverse reactions.

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?

Check the official report for specific batch details.

BENODIL

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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