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.

Out-of-specification results were found for atomoxetine content in seven batches and non-compliance in the mass uniformity parameter in batch 1311190, posing a real and direct risk to patients' health or life. Potential effects: reduced treatment efficacy, unstable drug effect, possible worsening of disease symptoms.

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Konaten
Risk Level
Critical
Manufacturer
Neuraxpharm Arzneimittel GmbHz siedzibą w Niemczech
Batch Number
1310715
Notice Date
28.05.2024
View official statement
Source: GIF view the official alert

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. 1

    Do not eat or use the product

    Stop using or consuming it immediately and keep it out of reach of children.

  2. 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. 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. 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 medicine from the listed batches, check the batch number on the packaging and return the product to a pharmacy; if in doubt about the medicine taken or in case of deterioration of healt...

Actions Taken

Distribution of the specified batches of Konaten was suspended throughout the country and the decision was given immediate enforceability; the manufacturer halted production of atomoxetine-containing ...

Need Help?

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

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Other Notices