Trazodone Neuraxpharm

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.

Stability test results showed that the hardness of some tablets was below the lower specification limit, which constitutes a real and direct threat to patients' health or life until the cause is clarified and any impact on the product’s efficacy and safety is excluded. Potential effects: lack of treatment efficacy, adverse reactions, complications.

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Risk Level

Critical

Manufacturer

Neuraxpharm Arzneimittel GmbH z siedzibą w Langenfeld, Niemcy

Batch Number

P2200932

Notice Date

09.10.2023

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 tablets from the specified batches; check the batch number on the packaging and, if you have this product, return it to the pharmacy and consult a doctor or pharmacist regarding further tre...

Actions Taken

The marketing of four batches of the medicinal product Trazodone Neuraxpharm was suspended throughout the country, and the decision was given immediate enforceability pending further clarifying procee...

Need Help?

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

Trazodone Neuraxpharm

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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