BDS N

Q: Is this product safe to consume?

No. This product has been recalled due to: Out-of-specification results were found in archival samples for the parameter of budesonide-related substances content, due to exceeded impurity levels. Potential effects: possible adverse effects, toxicity, or lack of expected drug efficacy.

Q: Which batches are affected?

Affected batch numbers: nie podano

Out-of-specification results were found in archival samples for the parameter of budesonide-related substances content, due to exceeded impurity levels. Potential effects: possible adverse effects, toxicity, or lack of expected drug efficacy.

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Risk Level

Critical

Manufacturer

Apotex Europe B.V. z siedzibą w Holandii

Batch Number

nie podano

Recall Date

07.08.2019

What You Should Know

Recommendations

Do not use the product from the withdrawn batches; patients should consult a doctor or pharmacist regarding further treatment and the possibility of exchanging packs at the pharmacy.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batches of the medicinal product BDS N from the market throughout the country and granted the decision immediate enforceability; the marketing authorization...

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 for the parameter of budesonide-related substances content, due to exceeded impurity levels. Potential effects: possible adverse effects, toxicity, or lack of expected drug efficacy.

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: nie podano

BDS N

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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