Sirdalud MR

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

It is not possible to guarantee specification-compliant release of tizanidine hydrochloride after 2 hours, and the cause is not fully understood, so the impact on product quality and safety of use cannot be predicted. Potential effects: lack of treatment efficacy or adverse effects related to incorrect dosing.

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Risk Level

Medium

Manufacturer

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

Batch Number

KJP80

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

Check the batch number of the medicine; if you possess batch KJP80, do not use the product and consult a pharmacist or doctor.

Actions Taken

The Chief Pharmaceutical Inspector banned placing batch KJP80 of Sirdalud MR 6 mg on the market throughout the country and granted the decision immediate enforceability; the batch was blocked at the m...

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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