Trazodone Neuraxpharm

GIF decision: Re-authorization for marketing

What does this decision mean?

• Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

An out-of-specification (OOS) result was recorded for the tablet hardness parameter, potentially linked to different blister foils and gas permeability, which could affect product hardness during storage. Potential effects: possible changes in active substance release, altered bioavailability and efficacy, although the investigation showed no significant impact.

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Risk Level

Low

Manufacturer

Neuraxpharm Arzneimittel GmbH z siedzibą w Langenfeld, Niemcy

Batch Number

P2200932

Notice Date

10.01.2024

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

Patients may use the medicine as prescribed; if they have any doubts or notice irregularities in the tablets, they should consult their doctor or pharmacist.

Actions Taken

The marketing of the specified batches was suspended, an investigation was conducted, the withdrawal procedure was discontinued, and then the decision to suspend marketing was declared expired as moot...

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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