BENODIL

Q: Is this product safe to consume?

No. This product has been recalled due to: Out-of-specification results were found in archival samples tested by the manufacturer, regarding the parameter of budesonide-related substances content, which means failure to meet established quality requirements. Potential effects: possible lack of treatment efficacy or unforeseen adverse reactions.

Out-of-specification results were found in archival samples tested by the manufacturer, regarding the parameter of budesonide-related substances content, which means failure to meet established quality requirements. Potential effects: possible lack of treatment efficacy or unforeseen 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Do not use the product from the withdrawn batches; patients should check batch numbers after the GIF communication and, in case of doubt, contact a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector decided to withdraw from the market throughout the country the batches of the medicinal product with a quality defect and granted the decision immediate enforceabili...

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: Out-of-specification results were found in archival samples tested by the manufacturer, regarding the parameter of budesonide-related substances content, which means failure to meet established quality requirements. Potential effects: possible lack of treatment efficacy or unforeseen 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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