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 (OOS) results were found for atomoxetine content in reference samples of several batches and a failure in the capsule mass uniformity parameter, caused among others by loss of active substance during filling and lack of full capsule weight control. Potential effects: reduced treatment effectiveness, possible worsening of disease symptoms.

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Risk Level

Low

Manufacturer

neuraxpharm Arzneimittel GmbH z siedziba w Niemczech

Batch Number

1304011

Notice Date

17.07.2024

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 Konaten (Atomoxetine) from the listed batches; check the batch number on the package; if you possess the product, return it to a pharmacy and consult a doctor or pharmacist if in doubt.

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches from the market nationwide, prohibited their further placing on the market and granted the decision immediate enforceability; the manu...

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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