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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 results were found for atomoxetine content, below the lower specification limit, and for one batch non‑compliant capsule mass uniformity; the risk assessment indicated mainly potentially reduced drug efficacy. Potential effects: lack of or reduced treatment effectiveness.

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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 product from the listed batches; check the batch number on the packaging and, if you have such medicine, return it to the pharmacy and consult a doctor if in doubt.

Actions Taken

The specified medicinal product batches were withdrawn from the market nationwide, their placing on the market was prohibited, and the decision was given immediate enforceability; previously, distribu...

Need Help?

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

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What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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