Atofab

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

Out-of-specification (OOS) results were found in reference samples for the atomoxetine content parameter, which may affect the quality and effectiveness of the medicine. Potential effects: lack or reduced treatment efficacy, possible worsening of disease symptom control.

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Risk Level

Medium

Manufacturer

G.L. Pharma GmbH z siedzibą w Austrii

Batch Number

E01580

Notice Date

09.08.2024

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 Atofab from batches E01580 and FQ6874, check the batch number on the pack; if you have these batches, consult a pharmacist or doctor to obtain an appropriate replacement or further advice.

Actions Taken

Suspension throughout the country of the marketing of batches E01580 and FQ6874 of the medicinal product Atofab (Atomoxetine), hard capsules, 25 mg and 40 mg, and granting the decision immediate enfor...

Need Help?

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

Atofab

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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