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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

For some batches reference samples showed out-of-specification atomoxetine content below the lower limit, and for one batch also non-compliant capsule mass uniformity. Potential effects: reduced treatment efficacy, risk of lack of therapeutic effect.

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Risk Level

Medium

Manufacturer

neuraxpharm Arzneimittel GmbH z siedzibą w Niemczech

Batch Number

1110197

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 specified batches of the medicine, check the batch number and expiry date on the pack, and if you have the product, return it to a pharmacy or consult your doctor about further steps.

Actions Taken

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

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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