ADRENALIN OSEL 1 mg/1 mL IM/IV/SC Solution for Injection

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Breaking of the ampoule and inability to open the medicine normally, creating uncertainty whether glass fragments entered the interior and contaminated the solution, posing a threat to the patient’s health and life. Potential effects: life‑threatening complications after injection, tissue damage, lack of effective treatment.

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ADRENALIN OSEL 1 mg/1 mL IM/IV/SC Solution for Injection

Risk Level

Critical

Manufacturer

OSEL İlaç San. ve Tic. A.Ş.; podmiot, który uzyskał zgodę Ministra Zdrowia na czasowe dopuszczenie do obrotu produktu leczniczego: ZF Polpharma S.A. z siedzibą w Starogardzie Gdańskim

Batch Number

22607001

Notice Date

23.02.2023

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 product from batch 22607001, check the batch number of any ampoules held, and return product from this batch to the pharmacy or supplier; if the medicine from this batch has been administer...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 22607001 of the medicinal product ADRENALIN OSEL 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.

ADRENALIN OSEL 1 mg/1 mL IM/IV/SC Solution for Injection

What to do if you have this product?

What You Should Know

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Actions Taken

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