Poland’s pharmaceutical inspectorate ordered the immediate withdrawal of Gastrografin, a diagnostic imaging drug, after detecting a potentially carcinogenic impurity.
Gastrografin Withdrawn Over Carcinogenic Contamination
The Main Pharmaceutical Inspectorate (GIF) issued a strict decision to immediately remove Gastrografin – a drug used in diagnostic imaging – from circulation. The reason is concerning: the product was found to contain N-nitroso-meglumine – a compound with potential carcinogenic effects.
The level of contamination exceeded permissible safety standards.
Why is Gastrografin Being Removed from Pharmacies?
The Main Pharmaceutical Inspectorate (GIF) announced the withdrawal of the medicinal product Gastrografin (Meglumini amidotrizoas + Natrii amidotrizoas) throughout the country due to the detection of a potentially dangerous impurity.
Bayer AG Alerts Regarding Gastrografin Research Results
The Main Pharmaceutical Inspectorate made the decision after analyzing the research results submitted by the manufacturer, Bayer AG. Bayer sp. z o.o, as the representative of Bayer AG, notified GIF of the assessment of impurities in the Gastrografin medicinal product.
The product was found to contain N-nitroso-meglumine, a compound classified as a potentially carcinogenic nitrosamine. The level of this substance in the tested batches exceeded permissible safety limits – both the standard daily intake limit and the temporary limits applied to sporadically used medications.
Details of the Withdrawn Product
[LISTA – Not provided in source]
GIF Responds to Carcinogenic Impurity in Gastrografin: What Was Decided?
The GIF reacted to the carcinogenic impurity in the Gastrografin drug.