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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Reduced content of the active substance – levothyroxine sodium – was found in the listed batches, which may lead to decreased effectiveness of the medicine and a health risk for the patient. Potential effects: reduced efficacy of hypothyroidism treatment, deterioration of health, recurrence of disease symptoms.

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Risk Level

Medium

Manufacturer

IBSA Farmaceutici Italia S.r.L., Włochy

Batch Number

220651

Notice Date

08.03.2023

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 medicine from the listed batches, check the batch number on the packaging, return the product to the pharmacy, and consult a doctor regarding further treatment and possible replacement ...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the indicated batches of the medicinal product from the market throughout the country, granted the decision immediate enforceability, and obliged the market...

Need Help?

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

Tirosint Sol

What to do if you have this product?

What You Should Know

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Actions Taken

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