Gastrografin (Meglumine amidotrizoate + Sodium amidotrizoate solution 0.76 g/mL)

Brief description of the problem (reason for recall)

Bayer has detected a risk for the formation of nitrosamine (N-Nitroso-Meglumine) in Gastrografin/Urografin.

• The evaluation of N-Nitroso-Meglumine showed a potential of mutagenicity in a mouse
• All formulations of meglumine amidotrizoate and sodium amidotrizoate (Gastrografin, Urografin) are exceeding the established limits for the acceptable intake of N- Nitroso-Meglumine in most tested

Advise for health professionals and distributors:

Please return all stocks of this batch to DSV Solutions, or the wholesaler/distributor that you purchased it from, for credit.

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.