Sirdalud MR

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

It is not possible to guarantee specification-compliant active substance release after 2 hours until the end of the shelf-life, which may affect the quality and safety of product use. Potential effects: lack of treatment efficacy or increased adverse effects.

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Risk Level

High

Manufacturer

Sandoz GmbH, Austria (uprzednio Novartis Poland sp. z o.o. z siedzibą w Warszawie)

Batch Number

KAN87

Notice Date

07.07.2023

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 the listed batches, check the batch number on the packaging and return any affected packs to a pharmacy; in case of doubt consult a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of Sirdalud MR from the market throughout the country and granted the decision immediate enforceability, obliging the marketing author...

Need Help?

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

Sirdalud MR

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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