Thioealth

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Control activities by the Voivodeship Pharmaceutical Inspector confirmed the presence of a piece of glass in one vial of the product, creating a direct risk to patients’ health or life during administration of the solution for injection. Potential effects: tissue damage, embolism, thromboembolic complications, life-threatening conditions.

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Risk Level

Critical

Manufacturer

podmiot odpowiedzialny: LIVEALTH BIOPHARMA PVT. L.T.D. podmiot, który uzyskał zgodę na czasowe dopuszczenie do obrotu produktu leczniczego: Salus International Sp. z o.o., ul. Pułaskiego 9, 40-273 Katowice

Batch Number

A0402001

Notice Date

19.10.2021

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 Thioealth from batch A0402001. Hospitals and pharmacies should immediately withdraw this batch from use and from stock. If the product has been administered to a patient, urgent medical con...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch A0402001 of the medicinal product Thioealth from the market nationwide and granted the decision immediate enforceability.

Need Help?

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

Thioealth

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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