The Medicines Control Authority of Zimbabwe (MCAZ) has issued a public alert regarding the voluntary recall of Meglumine Amidotrizoate / Sodium Amidotrizoate 0.3 / 0.6 / 0.76 g/mL (Urografin 60%) solution for Injection, a contrast agent used in X-ray and diagnostic imaging procedures.
The recall affects all batches manufactured between October 2020 and March 2025, due to the presence of an impurity, N-Nitroso-Meglumine (NO-Meglumine), at levels exceeding safety thresholds. This impurity has been shown to be genotoxic and potentially carcinogenic, prompting the recall as a precautionary measure.
Although Urografin 60% was registered in Zimbabwe in 2018, there is no record of its importation into the country between 2020 and 2026. However, the MCAZ is warning that the product may have entered the local market through unauthorized or illegal channels.
The authority urgef healthcare facilities, pharmacies, and wholesalers to ensure that the product is not in circulation or use. Members of the public and healthcare professionals were advised to refrain from using or administering the product and to report any suspected presence to the MCAZ or a qualified healthcare provider.
The MCAZ committed to intensify market surveillance activities to prevent the circulation of the potentially harmful product and safeguarding public and animal health.
