Auroverin MR

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

The test showed that the release of mebeverine hydrochloride was slower than allowed by quality requirements, which affects the product’s effectiveness and poses a real and direct threat to patients’ health or life. Potential effects: lack of treatment efficacy, possible worsening of symptoms, complications.

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Risk Level

Critical

Manufacturer

Aurovitas Pharma Polska sp. z o.o. z siedzibą w Warszawie

Batch Number

EMBCD2064A

Notice Date

22.12.2023

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 batch EMBCD2064A. Patients should check the batch number of their medicine and, if it matches, return the product to the pharmacy or consult a doctor.

Actions Taken

The distribution of Auroverin MR batch EMBCD2064A was suspended nationwide and the decision was given immediate enforceability after negative quality test results from the National Medicines Institute...

Need Help?

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

Auroverin MR

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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