Atofab

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 for atomoxetine content and non-uniform capsule mass, which may reduce product efficacy. Potential effects: reduced or absent therapeutic effect.

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Risk Level

High

Manufacturer

G.L. Pharma GmbH z siedzibą w Austrii

Batch Number

E01580

Notice Date

20.09.2024

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 products from the listed batches. Check batch number and expiry date; return the product to the pharmacy or the marketing authorisation holder; consult a physician if concerned.

Actions Taken

Withdrawal of the specified batches from the national market; ban on placing these batches on the market; decision effective immediately; prior suspension of distribution of these batches.

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

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Actions Taken

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