PRESARTAN

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Impurities of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) were detected in the active substance Losartanum kalicum from the manufacturer Zhejiang Huahai Pharmaceutical Co. Ltd. Potential effects: possible carcinogenic effects and health risks with long-term use.

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Risk Level

Critical

Manufacturer

PharmaSwiss Česká republika s.r.o., Republika Czeska

Notice Date

12.03.2019

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Do not use or dispense the withdrawn losartan-containing products from the indicated manufacturer; patients should contact their doctor or pharmacist to determine further treatment.

Actions Taken

The Chief Pharmaceutical Inspector issued a decision on the immediate withdrawal from the market of medicinal products containing the active substance losartan potassium with NDMA and NDEA impurities ...

Need Help?

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

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