LOREBLOK

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Contamination with N-nitroso-N-methylamino butyric acid (NMBA) was detected in some batches of the losartan active substance (from Hetero Labs Limited). Potential effects: increased risk of carcinogenic effects with long-term exposure.

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Risk Level

Critical

Manufacturer

Orion Corporation z siedzibą w Finlandii

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 Loreblok or Loreblok HCT batches originating from Hetero Labs; return them to the pharmacy or distributor. If in doubt or if symptoms occur, contact a physician.

Actions Taken

Decision to withdraw and prohibit the marketing of batches containing losartan potassium from Hetero Labs; decision made immediately enforceable; obligation to take immediate actions in accordance wit...

Need Help?

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

LOREBLOK

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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