Lakea

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Exceeding the limit of impurity 5-[4'-[(5-(azidomethyl)-2-butyl-4-chloro-1H-imidazol-1-yl)methyl]-[1,1'-biphenyl]-2-yl]-1H-tetrazole was found in the active substance used to manufacture the tablets. Potential effects: possible toxic effects and lack of full therapy safety.

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Risk Level

Medium

Manufacturer

Sandoz GmbH

Batch Number

KW1650

Notice Date

20.09.2021

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 tablets from the listed batches, check the batch number on the packaging, return the product to the pharmacy if you have it, and consult a doctor in case of doubts or adverse symptoms.

Actions Taken

The Lakea batches KW1650, LG4000 and LG4001 were withdrawn from the market nationwide and the decision was given immediate enforceability.

Need Help?

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

Lakea

What to do if you have this product?

What You Should Know

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Actions Taken

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