Bisoratio ASA

Q: Is this product safe to consume?

No. This product has been recalled due to: An out-of-specification result was found in stability testing for the parameter bisoprolol fumarate related substances: another single impurity. The probability of adverse reactions after exposure to the product cannot be excluded. Potential effects: possible adverse reactions, including toxic symptoms or reduced treatment efficacy.

An out-of-specification result was found in stability testing for the parameter bisoprolol fumarate related substances: another single impurity. The probability of adverse reactions after exposure to the product cannot be excluded. Potential effects: possible adverse reactions, including toxic symptoms or reduced treatment efficacy.

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Risk Level

Medium

Manufacturer

Actavis Group PTC ehf.

Batch Number

10320

EAN Code

05909990961894

Recall Date

07.12.2022

What You Should Know

Recommendations

Do not use capsules from batch 10320. If you have this product, return it to a pharmacy and consult a doctor or pharmacist if in doubt.

Actions Taken

The medicinal product Bisoratio ASA, 5 mg + 75 mg, hard capsules, batch number 10320, was withdrawn from the market throughout the country, with immediate enforceability and an obligation on the marke...

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: An out-of-specification result was found in stability testing for the parameter bisoprolol fumarate related substances: another single impurity. The probability of adverse reactions after exposure to the product cannot be excluded. Potential effects: possible adverse reactions, including toxic symptoms or reduced treatment 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: 10320

Bisoratio ASA

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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