Auroverin 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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 the batch does not meet quality requirements due to a negative test result for the mebeverine hydrochloride release parameter, which may lead to improper release and reduced therapeutic efficacy. Potential effects: lack of efficacy, 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 specified batches of the medicine. Check the batch number on the package and, if you have the product, return it to the pharmacy. If in doubt or if symptoms occur, contact a doctor or p...

Actions Taken

The specified batches of the medicinal product were withdrawn from the market nationwide and a ban on placing them on the market was issued, with the decision given immediate enforceability.

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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