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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Particles were detected in some ampoules of the concentrate for solution for injection or infusion, which according to the specification should be clear, light yellow and free from visible particles. Potential effects: risk of emboli, local reactions, circulatory complications or other serious complications during intravenous administration.

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Risk Level

Critical

Manufacturer

Hameln Pharma GmbH

Batch Number

047502A

Notice Date

25.06.2021

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 product from batch 047502A; check the batch number of ampoules you hold; in case of doubts, contact a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 047502A of the medicinal product from the market nationwide and granted the decision immediate enforceability, obliging the marketing authorisation ho...

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

Recommendations

Actions Taken

Need Help?

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