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 capsule mass uniformity (OOS) detected in reference tests. Potential effects: reduced efficacy of the medicine.

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Atofab
Risk Level
High
Manufacturer
G.L. Pharma GmbH z siedzibą w Austrii
Batch Number
F06874
Notice Date
20.09.2024
View official statement
Source: GIF view the official alert

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. 1

    Do not eat or use the product

    Stop using or consuming it immediately and keep it out of reach of children.

  2. 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. 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. 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 specified batches; check batch number and expiry date; return the product to the pharmacy or distributor; contact a doctor or pharmacist if in doubt.

Actions Taken

Withdrawal from the national market of the specified batches; prohibition of placing on the market; decision enforceable immediately; prior suspension of distribution and initiation of administrative ...

Need Help?

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

Related

Other Notices