Sirdalud MR

Q: Is this product safe to consume?

No. This product has been recalled due to: 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.

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

EAN Code

05909990671410

Recall Date

07.04.2023

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.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: 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.

What should I do if I already bought this?

Stop using the product immediately. Return it to the store for a full refund. If you consumed it and feel unwell, contact your doctor.

Which batches are affected?

Affected batch numbers: KDF58

Sirdalud MR

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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