Bisoratio ASA

Q: Is this product safe to consume?

No. This product has been recalled due to: Out-of-specification results were found for the parameter of related substances and total bisoprolol impurities during long-term 12‑month stability studies, which may affect the safety and efficacy of the medicine. Potential effects: reduced treatment effectiveness, adverse reactions, cardiovascular complications.

Out-of-specification results were found for the parameter of related substances and total bisoprolol impurities during long-term 12‑month stability studies, which may affect the safety and efficacy of the medicine. Potential effects: reduced treatment effectiveness, adverse reactions, cardiovascular complications.

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Risk Level

Medium

Manufacturer

Actavis Group PTC ehf., Islandia

Batch Number

10819

EAN Code

05909990961894

Recall Date

05.08.2021

What You Should Know

Recommendations

Do not use product from batch 10819, check the batch number on your pack, and if you have it, return the medicine to a pharmacy; if you have taken the medicine, consult a doctor.

Actions Taken

Withdrawal from the market across the entire country of the medicinal product Bisoratio ASA, batch 10819, and granting 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 for the parameter of related substances and total bisoprolol impurities during long-term 12‑month stability studies, which may affect the safety and efficacy of the medicine. Potential effects: reduced treatment effectiveness, adverse reactions, cardiovascular complications.

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: 10819

Bisoratio ASA

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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