Konaten

GIF decision: Withdrawal from market

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Out-of-specification (OOS) results were found for atomoxetine content, below the lower specification limit, and in one batch also non-compliance in the mass uniformity parameter. The risk assessment points mainly to a possibility of reduced treatment effectiveness. Potential effects: absence or reduction of therapeutic efficacy.

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Risk Level

Medium

Manufacturer

neuraxpharm Arzneimittel GmbH, z siedzibą w Niemczech

Batch Number

1211303

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 affected batches of Konaten (Atomoxetine). Patients should consult their doctor or pharmacist to ensure continuity of treatment and to arrange the return of defective packs to the pharm...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of Konaten from the national market, prohibited their placing on the market, and granted the decision immediate enforceability; previo...

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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