Online Reporter
Tendai Gukutikwa
Health Reporter
THE Medicines Control Authority of Zimbabwe (MCAZ) has issued a public health alert warning healthcare providers and consumers against the use of a diagnostic imaging injection, while also recalling a batch of a commonly used digestive remedy amid growing concerns over product safety.
The alert centres on Urografin 60%, a contrast agent used in X-ray and other diagnostic imaging procedures, as well as Citro Soda sachets, which are widely used to relieve indigestion and stomach discomfort.
Urografin 60% contains meglumine amidotrizoate and sodium amidotrizoate, compounds that are administered into the body to enhance the visibility of internal organs, blood vessels and tissues during imaging procedures such as X-rays and CT scans.
These contrast agents play a critical role in modern medicine, helping clinicians diagnose conditions such as tumours, urinary tract blockages, gastrointestinal disorders and vascular abnormalities with greater accuracy.
In the circular, MCAZ Director General, Mr Richard Rukwata announced that all batches of Urografin 60% manufactured between October 2020 and March 2025 have been recalled following new scientific findings.
“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.
“Recent in-vivo (animal) studies have confirmed that the impurity N-Nitroso-Meglumine is genotoxic and potentially carcinogenic.
“Based on this new scientific evidence, the acceptable daily intake limit for this impurity has been significantly reduced to ensure patient safety,” said Mr Rukwata.
He explained that recent in-vivo studies confirmed the impurity can damage genetic material, and potentially raising serious concerns about long-term exposure.
Although the product was registered for use in Zimbabwe in 2018, MCAZ indicated that there are no official records showing that the affected batches were imported into the country between 2020 and 2026.
The product is manufactured in South Africa.
However, authorities warned that this does not entirely eliminate the risk of the product being available locally.
“This follows a critical communication received from Bayer Pty Ltd, South Africa, regarding a voluntary recall of Urografin 60%, a contrast agent used for X-ray and diagnostic imaging.
“The recall applies to all batches which were manufactured from October 2020 to March 2025.
“Nevertheless, there remains a concern that the affected batches of Urografin 60% could have been introduced into the local market through unauthorised or illegal channels. As a precautionary measure, the Authority is therefore issuing a formal alert for this product,” said Mr Rukwata.
He urged healthcare institutions, wholesalers, pharmacies and members of the public to remain vigilant and avoid administering or using the product if encountered.
“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.
“Stakeholder cooperation is vital to safeguard public access to safe and quality medicines.
“The Authority will intensify market surveillance through enhanced premises inspections and public awareness to prevent the circulation of this product,” he said.
Meanwhile, MCAZ has also ordered the recall of batch number C134584 of Citro Soda sachets, a popular over-the-counter remedy used to relieve symptoms of acid indigestion, heartburn and bloating.
Citro Soda contains a combination of citric acid, sodium citrate, bicarbonate and tartaric acid, which work together to neutralise excess stomach acid and provide quick relief from digestive discomfort.
The product is commonly used in households and is widely available in pharmacies and retail outlets.
According to MCAZ, the affected batch, manufactured by Adcock Ingram Limited in South Africa, is being recalled after the identification of potential foreign material contamination during a factory inspection.
“The reported batch of Citro Soda is being recalled following the identification of potential foreign material contamination. The issue was detected during an inspection of the manufacturing site conducted by the South African Health Products Regulatory Authority Inspectorate,” said Mr Rukwata.
He warned that failure to meet product quality specifications could result in harm to patients if the contaminated batch is consumed.
“The Authority would like to draw attention of all licensed wholesalers, pharmacies, public and private clinics and hospitals that they should quarantine any of the affected units of the reported product and cooperate with Adcock Ingram Ltd and local distributors during the recall process,” he said.
He advised members of the public who may have purchased the affected batch to return it to the pharmacy where it was obtained to prevent potential health risks.
Mr Rukwata stressed the importance of cooperation among all stakeholders, including healthcare providers, suppliers and consumers, in safeguarding public health.
“Stakeholder cooperation is vital to safeguard public access to safe and quality medicines.
“The Authority will intensify market surveillance through enhanced premises inspections and public awareness to prevent the circulation of this product,” he said.
