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 results were found for atomoxetine content and non-uniform capsule mass in batches manufactured from the same bulk batches; risk assessment indicates possible reduced therapeutic efficacy. Potential effects: possible treatment failure and worsening of disease symptoms.

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Risk Level

Medium

Manufacturer

G.L. Pharma GmbH z siedzibą w Austrii

Batch Number

F06874

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 capsules from batches E01580 and FQ6874/F06874. Check the batch number on the pack; if you have these batches, return them to the pharmacy and consult a doctor if in doubt.

Actions Taken

The Chief Pharmaceutical Inspector suspended the distribution of Atofab 25 mg and 40 mg batches E01580 and FQ6874/F06874 throughout the country and granted the decision immediate enforceability; the p...

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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