Bisoratio ASA

GIF decision: Withdrawal from market

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

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

Notice Date

07.12.2022

What to do if you have this product?

A recall means the product may be unsafe. Here is what to do if you have it at home.

1

Do not eat or use the product

Stop using or consuming it immediately and keep it out of reach of children.
2

Check the batch number and expiry date

Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.
3

Return it to the shop

You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.
4

Get help and report it

If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.

General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.

Important Information

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The medicinal product Bisoratio ASA, 5 mg + 75 mg, hard capsules, batch number 10320, was withdrawn from the market throughout the country, with immediate enforceability and an obligation on the marke...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

Bisoratio ASA

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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