Clarithromycin hameln

GIF decision: Withdrawal from market, Marketing prohibition

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

Lack of confirmed quality of the active substance used for batch 25D052 and non-compliance with GMP requirements in the supply chain. The product is a solution for infusion, so potential quality deviations carry an increased risk to patients' health and life. Potential effects: poisoning, lack of efficacy, complications during intravenous therapy.

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Risk Level

Critical

Manufacturer

hameln Pharma GmbH z siedzibą w Hameln, Niemcy

Batch Number

25D052

Notice Date

18.12.2025

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 Clarithromycin hameln 500 mg from batch 25D052. Check the batch number on the package before using the medicine. If you have packages from this batch, return them to a pharmacy or consult y...

Actions Taken

Withdrawal from the market throughout the entire country of Clarithromycin hameln 500 mg, powder for concentrate for solution for infusion, batch 25D052. Ban on placing batch 25D052 on the market. The...

Need Help?

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

Clarithromycin hameln

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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