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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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 limit and, for one batch, non-compliant capsule mass uniformity, leading to a reduced dose of the medicine. Potential effects: reduced treatment efficacy, worsening of disease symptoms.

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Risk Level

Low

Manufacturer

neuraxpharm Arzneimittel GmbH, z siedziba w Niemczech

Batch Number

1202428

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 batches covered by the decision; check the batch number and expiry date on the package. If you have a product from these batches, return it to the pharmacy and consult your doctor or ph...

Actions Taken

Withdrawal from the market throughout the country of the specified batches, prohibition of placing these batches on the market, granting the decision immediate enforceability, and suspension of manufa...

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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