APO-LOZART

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Detected contamination with N-nitroso-N-methylamino butyric acid (NMBA) in some batches of the losartan potassium active substance. Potential effects: carcinogenicity, increased long-term health risk.

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Risk Level

Critical

Manufacturer

Apotex Europe B.V. z siedzibą w Holandii

Notice Date

01.02.2019

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 products from suspected batches; check the batch number with the pharmacy or manufacturer and return the product; consult a physician if in doubt.

Actions Taken

Decision of the Chief Pharmaceutical Inspector to prohibit placing on the market and to immediately withdraw batches of the medicinal product containing the active substance originating from Hetero La...

Need Help?

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

APO-LOZART

What to do if you have this product?

What You Should Know

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Actions Taken

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