Dutilox antidepressant recalled in Poland due to contamination

The Chief Pharmaceutical Inspector (GIF) has issued an immediate nationwide recall and temporary ban on several formats of the antidepressant medication Dutilox (Duloxetinum) in Poland. The decision affects both 30 mg and 60 mg hard gastrointestinal capsules.

Specifically, the GIF has ordered the withdrawal of all series for the 28-capsule and 56-capsule packaging variants for both the 30 mg and 60 mg doses. For all other packaging sizes and formats, a temporary ban on introducing the product to the market has been implemented.

The recall was triggered by the detection of N-nitroso-duloxetine contamination, which significantly exceeds the acceptable threshold (LTL) during the product's declared shelf life. This contamination poses a potential risk to public health. The responsible entity for the product is Farmak International Sp. z o. o., based in Warsaw. The decision follows a notification from the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.