Tirosint Sol

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

A reduced content of the active substance (levothyroxine) was found in five batches, with out-of-specification results and levels below the established limit, which may lead to decreased drug effectiveness and health risk for patients. Potential effects: reduced efficacy of hypothyroidism treatment, possible worsening of disease symptoms.

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Risk Level

Medium

Manufacturer

IBSA Farmaceutici Italia S.r.l. z siedzibą we Włoszech

Batch Number

220657

Notice Date

21.02.2023

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, and contact a doctor or pharmacist in case of doubts or worsening of well-being.

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of TIROSINT SOL from the entire national market and granted the decision immediate enforceability, obliging the marketing authorizatio...

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

Recommendations

Actions Taken

Need Help?

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