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

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

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Risk Level

Critical

Manufacturer

Apotex Europe B.V. z siedzibą w Holandii

Recall Date

07.08.2019

What You Should Know

Recommendations

Do not use the product from the withdrawn batches, check the batch in the pharmacy and, if possessed, return the product to the pharmacy or manufacturer; if adverse symptoms occur, contact a doctor.

Actions Taken

The Chief Pharmaceutical Inspector issued a decision to withdraw the batches of the medicinal product BDS N from the market throughout the country and granted the decision immediate enforceability.

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 regarding the parameter "content of budesonide-related substances", due to exceeded impurity levels. Potential effects: possible adverse reactions, toxicity, or lack of expected therapeutic 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?

Check the official report for specific batch details.

BDS N

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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