Konaten

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

In testing of reference samples from several batches, results outside the quality specification were found for atomoxetine content and, for one batch, non-compliance in mass uniformity, which constitutes a real and direct risk to patients’ health or life. Potential effects: reduced treatment efficacy, possible worsening of disease symptom control.

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Risk Level

Medium

Manufacturer

Neuraxpharm Arzneimittel GmbH z siedzibą w Niemczech

Batch Number

1211303

Notice Date

28.05.2024

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 the specified batches of the medicine. Check the batch number on the packaging; if you possess a product from these batches, return it to the pharmacy and consult your doctor regarding furt...

Actions Taken

The distribution of specified batches of Konaten was suspended throughout the country, and the decision was given immediate enforceability. The manufacturer re-tested the batches and halted the manufa...

Need Help?

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

Konaten

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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