Heviran

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 consisting in placing, in some packs of Heviran 400 mg film-coated tablets, a package leaflet in Lithuanian intended for Furosemid Polpharma 40 mg tablets. Potential effects: improper use of the medicine, lack of correct information on dosage, adverse reactions and precautions.

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Risk Level

High

Manufacturer

Zakłady Farmaceutyczne Polpharma Spółka Akcyjna

Batch Number

10522

Notice Date

22.07.2022

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 10522, check the batch number on the pack and, if you have this product, return it to the pharmacy or consult a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 10522 of Heviran 400 mg film-coated tablets from the market nationwide, granted the decision immediate enforceability, and obliged the marketing autho...

Need Help?

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

Heviran

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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