MORFİN HİDROKLORÜR Osel 0.01 g/1 ml

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Lack of efficient and safe opening of ampoules, irregular breaking, injuries to staff and glass crumbling that may enter the ampoule interior and pose a risk to patients. Potential effects: cuts, contamination of the solution with glass, complications after intravenous administration.

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Risk Level

Critical

Manufacturer

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

Batch Number

21646005

Notice Date

08.03.2023

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 21646005; check the batch number and return ampoules to the pharmacy or hospital. If medicine from a potentially contaminated ampoule was administered, contact a doctor.

Actions Taken

Withdrawal of batch 21646005 of the medicinal product from the entire national market and granting the decision immediate enforceability; obligating the company to carry out recall actions in accordan...

Need Help?

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

MORFİN HİDROKLORÜR Osel 0.01 g/1 ml

What to do if you have this product?

What You Should Know

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Actions Taken

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