Atofab

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  • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 results for atomoxetine content and non-uniform capsule mass caused by manufacturing defects and changed API particle properties. Potential effects: reduced efficacy of the medicine.

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Atofab
Risk Level
Medium
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 batches E01580 and F06874; check the batch number; return the product to the pharmacy or the marketing authorisation holder; consult a doctor or pharmacist if in doubt.

Actions Taken

Withdrawal from the national market of the specified batches; prohibition of placing these batches on the market; decision given immediate enforceability; prior suspension of distribution by decision ...

Need Help?

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

Related

Other Notices