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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 was found that batch KDF58 does not meet the requirements for the mean value of tizanidine hydrochloride release at 2 hours, and the cause of this deviation is unknown, so the impact on product quality, safety of use and the risk to patients’ health cannot be predicted. Potential effects: overdose or insufficient drug effect, treatment complications.

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Risk Level

High

Manufacturer

Novartis Poland sp. z o.o. z siedzibą w Warszawie zmieniony decyzją Prezesa Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych z dnia 31.10.2022 r. na Sandoz GmbH z siedzibą w Austrii

Batch Number

KDF58

Notice Date

07.04.2023

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 Sirdalud MR from batch KDF58, check the batch number on the packaging and return the product to the pharmacy; consult a doctor if in doubt.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch KDF58 of Sirdalud MR 6 mg from the market throughout the country and granted the decision immediate enforceability; the marketing authorisation holder...

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?

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