The Medicines Control Authority of Zimbabwe has issued a public health alert warning healthcare institutions and consumers against the use of a recalled contrast injection drug linked to potential cancer risks.
In Circular No. 05 of 2026 dated March 19, the medicines regulator alerted licensed pharmacies, wholesalers, hospitals, clinics and the public about the voluntary recall of Meglumine Amidotrizoate/Sodium Amidotrizoate 0.3/0.6/0.76 g/ml (Urografin 60%) solution for injection.
The authority said the communication followed a critical safety notice received from Bayer Pty Ltd South Africa concerning specific batches of the diagnostic contrast agent used during X-ray imaging procedures.
“The Medicines Control Authority of Zimbabwe would like to inform all stakeholders of a critical communication received from Bayer Pty Ltd, South Africa, regarding a voluntary recall of specific batches of Meglumine Amidotrizoate/Sodium Amidotrizoate 0.3/0.6/0.76 g/ml (Urografin 60%) solution for injection,” the authority said.
According to MCAZ, confirmatory testing detected the presence of an impurity identified as N-Nitroso-Meglumine, which exceeds newly established international safety limits.
“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 circular reads.
The regulator warned that recent animal studies have shown the impurity to be harmful.
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“Recent in-vivo (animal) studies have confirmed that the impurity N-Nitroso-Meglumine is genotoxic and potentially carcinogenic,” MCAZ said.
Although the product was registered locally in 2018, MCAZ noted that importation records do not show evidence of official entry into Zimbabwe between 2020 and 2026. However, authorities fear the medicine could still reach patients through informal supply chains.
“While the Authority confirms that this product was registered in Zimbabwe in 2018, 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 of Urografin 60% could have been introduced into the local market through unauthorized or illegal channels,” the regulator said.
MCAZ urged healthcare workers and the public to immediately report any suspected presence of the drug and to avoid administering it to patients.
“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 circular stated.
The authority added that it will intensify inspections and market surveillance to prevent circulation of the affected medicine.
“Stakeholder cooperation is vital to safeguard public access to safe and quality medicines,” MCAZ said, adding that enhanced premises inspections and public awareness campaigns will be implemented as a precautionary measure.
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