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Zimbabwe issues alert over recalled X-ray contrast agent
1 hr ago |
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The Medicines Control Authority of Zimbabwe has issued a public safety alert following a voluntary recall of Urografin 60%, a contrast agent used in X-ray and diagnostic imaging procedures.
The recall affects Meglumine Amidotrizoate / Sodium Amidotrizoate 0.3 / 0.6 / 0.76 g/mL solution for injection, commonly known as Urografin 60%, and follows a critical notification from Bayer Pty Ltd. According to the manufacturer, all batches produced between October 2020 and March 2025 are impacted.
Authorities said the recall was triggered after confirmatory tests detected an impurity known as N-Nitroso-Meglumine (NO-Meglumine) at levels exceeding newly established safety thresholds.
Recent scientific findings have classified the impurity as genotoxic and potentially carcinogenic, prompting a significant reduction in acceptable intake limits to protect patient health.
The MCAZ confirmed that Urografin 60% was registered in Zimbabwe in 2018. However, it noted that there are no official records of the product being imported into the country between 2020 and 2026.
Despite this, the authority warned of a possible risk of illegal or unauthorised entry into the local market.
Healthcare professionals, pharmacies, wholesalers and the general public have been urged to remain vigilant and ensure the product is not in circulation or use.
"Members of the public and healthcare professionals who encounter Urografin 60% are strongly advised to refrain from using or administering the product," the authority said.
Any suspected presence of the product should be immediately reported to the MCAZ or a qualified healthcare provider.
The authority said it will intensify market surveillance and inspections, alongside public awareness campaigns, to prevent distribution of the potentially harmful medicine.
MCAZ Director-General Richard T. Rukwata reaffirmed the regulator's commitment to protecting public health.
"The Authority remains committed to safeguarding public and animal health by ensuring that all medicines in Zimbabwe meet the highest standards of safety, quality and efficacy," he said.
The recall affects Meglumine Amidotrizoate / Sodium Amidotrizoate 0.3 / 0.6 / 0.76 g/mL solution for injection, commonly known as Urografin 60%, and follows a critical notification from Bayer Pty Ltd. According to the manufacturer, all batches produced between October 2020 and March 2025 are impacted.
Authorities said the recall was triggered after confirmatory tests detected an impurity known as N-Nitroso-Meglumine (NO-Meglumine) at levels exceeding newly established safety thresholds.
Recent scientific findings have classified the impurity as genotoxic and potentially carcinogenic, prompting a significant reduction in acceptable intake limits to protect patient health.
The MCAZ confirmed that Urografin 60% was registered in Zimbabwe in 2018. However, it noted that there are no official records of the product being imported into the country between 2020 and 2026.
Despite this, the authority warned of a possible risk of illegal or unauthorised entry into the local market.
Healthcare professionals, pharmacies, wholesalers and the general public have been urged to remain vigilant and ensure the product is not in circulation or use.
"Members of the public and healthcare professionals who encounter Urografin 60% are strongly advised to refrain from using or administering the product," the authority said.
Any suspected presence of the product should be immediately reported to the MCAZ or a qualified healthcare provider.
The authority said it will intensify market surveillance and inspections, alongside public awareness campaigns, to prevent distribution of the potentially harmful medicine.
MCAZ Director-General Richard T. Rukwata reaffirmed the regulator's commitment to protecting public health.
"The Authority remains committed to safeguarding public and animal health by ensuring that all medicines in Zimbabwe meet the highest standards of safety, quality and efficacy," he said.
Source - byo24news
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