Auroverin 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.

This batch does not meet the specified quality requirements due to a negative test result for the mebeverine hydrochloride release parameter. Potential effects: reduced effectiveness in treating intestinal disorders, possible worsening of disease symptoms.

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Risk Level

Medium

Manufacturer

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

Batch Number

EMBCD2064A

Notice Date

20.03.2024

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 specified batches. Check the batch number on the package; if you have the medicine, return it to the pharmacy and consult your doctor or pharmacist about further treatm...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of Auroverin MR from the market throughout the country and prohibited their placing on the market, granting the decision immediate enf...

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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