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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 decrease in active substance content below the limit and out-of-specification results for levothyroxine content were found, which may lead to reduced effectiveness of the medicine, and a risk to patient health cannot be excluded. Potential effects: reduced treatment effectiveness, worsening of disease symptoms, possible complications resulting from hypothyroidism.

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Risk Level

Medium

Manufacturer

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

Batch Number

220554

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 product from the listed batches, check the batch number on the packaging and, if you possess these packs, contact a pharmacist or doctor to replace the medicine or determine further tre...

Actions Taken

The specified batches of the medicinal product TIROSINT SOL were withdrawn from the market throughout the country and the decision was given immediate enforceability; the marketing authorisation holde...

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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