Zimbabwe’s medicines regulator, Medicines Control Authority of Zimbabwe (MCAZ), has issued a public alert following the recall of a diagnostic imaging product over safety concerns linked to harmful impurities.
MCAZ said the recall affects all batches of Urografin 60%, a solution for injection used in X-ray and diagnostic imaging procedures.
In a statement issued last Friday, the authority said it received communication from Bayer Pty Ltd regarding a voluntary recall of Meglumine Amidotrizoate and Sodium Amidotrizoate formulations manufactured between October 2020 and March 2025.
MCAZ said the recall was triggered by the detection of an impurity identified as N-Nitroso-Meglumine.
“This recall follows confirmatory testing which revealed the presence of an impurity known as N-Nitroso-Meglumine (NO-Meglumine) in the product at levels exceeding the newly established safety limits,” the authority said.
It added that recent studies have raised serious health concerns about the impurity.
“Recent in-vivo (animal) studies have confirmed that the impurity N-Nitroso-Meglumine is genotoxic and potentially carcinogenic,” reads part of the statement.
The authority, however, noted that there is no record of the product being officially imported into Zimbabwe in recent years.
“Our importation records show no evidence of its entry into the country between 2020 and 2026. Nevertheless, there remains a concern that the affected batches could have been introduced into the local market through unauthorized or illegal channels,” MCAZ said.
Director-General Richard Tendayi Rukwata said the alert is a precautionary measure to protect public health.
“Patient safety is our top priority, and we are taking this step to ensure that no harmful products are used within our healthcare system,” he said.
MCAZ has urged healthcare providers and members of the public to be vigilant and report any suspected presence of the product.
“In the unlikely event that members of the public encounter Urografin 60%, they are urged to immediately notify the Authority or a healthcare provider and refrain from administering it to patients,” the statement said.
The authority also called for cooperation from all stakeholders.
“Stakeholder cooperation is vital to safeguard public access to safe and quality medicines,” it said.
MCAZ said it will intensify inspections and public awareness campaigns to prevent the circulation of the recalled product.
