Mitocin 20 mg

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

In batch no. 0-20022AB an out-of-specification result was found due to the presence of visible particles in the product intended for solution for injection. Potential effects: embolism, inflammation, inflammatory reactions, local or systemic complications.

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Risk Level

Critical

Manufacturer

podmiot odpowiedzialny: Vygoris Limited podmiot, który uzyskał zgodę na czasowe dopuszczenie do obrotu produktu leczniczego: Profarm Sp. z o.o. ul. Słoneczna 96, 05-500 Stara Iwiczna

Batch Number

0-20022AB

Notice Date

17.09.2021

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 the product from batch 0-20022AB. Entities holding this batch should immediately stop its use and return it to the wholesaler. Patients who received the product from this batch and experien...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 0-20022AB of Mitocin 20 mg from the market throughout the country 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.

Mitocin 20 mg

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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