ASANIX

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

A quality defect was found: in the ongoing stability testing program an out-of-specification result was obtained for the parameter of active substance release from the tablet, meaning the drug may not release the correct amount of active ingredient. Potential effects: lack of treatment efficacy or unpredictable drug action.

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Risk Level

High

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Notice Date

28.06.2019

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Do not use the product from the withdrawn batch; patients should contact a doctor or pharmacist to determine further treatment and may return the medicine to a pharmacy.

Actions Taken

The Chief Pharmaceutical Inspector issued a decision to withdraw the specified batch of the medicinal product Asanix from the market throughout the country and granted the decision immediate enforceab...

Need Help?

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

ASANIX

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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