Konaten

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

Out-of-specification (OOS) results were found in reference samples for atomoxetine content, below the lower specification limit; for one batch also non-compliance in capsule mass uniformity; the impact on safety was assessed as low. Potential effects: reduced treatment effectiveness, possible worsening of symptoms, risk of complications due to poor disease control.

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Risk Level

Medium

Manufacturer

neuraxpharm Arzneimittel GmbH z siedzibą w Niemczech

Batch Number

1111121

Notice Date

28.08.2024

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 product from the listed batches. Patients should check the batch number on the pack, return any affected product to the pharmacy, and consult a doctor or pharmacist about the need for a...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of Konaten (Atomoxetine) from the market nationwide, prohibited their placing on the market, and granted the decision immediate enforc...

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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