Angusta

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Given that the cause of the out-of-specification result for an unknown impurity and its impact on the product quality and safety of use are currently unknown, it cannot be ruled out that keeping this product on the market may pose a threat to patient health. Potential effects: threat to patient health.

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Risk Level

High

Manufacturer

Norgine B.V. z siedzibą w Holandii

Batch Number

B26789

Notice Date

28.06.2022

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 the product from batch B26789; patients who have this product should contact their doctor or pharmacist and return the package to a pharmacy.

Actions Taken

Withdrawal from the market throughout the country of batch B26789 of Angusta (Misoprostolum); the decision was given immediate enforceability.

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

Angusta

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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