Amiodaron Hameln

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Increased crystallization of the product was found in the concentrate for solution for injection or infusion, which may affect the safety and efficacy of intravenous administration. Potential effects: vascular embolism, lack of treatment efficacy, intravenous complications.

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Risk Level

Critical

Manufacturer

hameln pharma gmbh

Batch Number

139503A

Notice Date

19.07.2022

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 139503A, check the batch number and return the product to the pharmacy; if the product has been used, contact a doctor.

Actions Taken

Withdrawal from the market throughout the entire country of batch 139503A of the medicinal product Amiodaron Hameln, with the decision given immediate enforceability.

Need Help?

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

Amiodaron Hameln

What to do if you have this product?

What You Should Know

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Actions Taken

Need Help?

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