Gastrografin Solution: Voluntary recall due to risk of impurity N-Nitroso-Meglumine exceeding the acceptable intake limits

A Dear Healthcare Professional Letter has been issued by Bayer (South East Asia) Pte Ltd to inform healthcare professionals about the voluntary recall of all formulations of Gastrografin (meglumine amidotrizoate and sodium amidotrizoate) as a precautionary measure due to the recent detection of N-Nitroso-Meglumine exceeding the acceptable intake limits. Similar to other nitrosamines, N-Nitroso-Meglumine is a probable carcinogen as it showed a potential of mutagenicity in a mouse study. The testing levels far exceeded the product testing results and were many times greater than would be expected in human use of the product. The clinical likelihood of harm is considered low, based on the estimated lifetime patient exposure to these contrast media and the lack of clinical manifestations from a cumulative review of company’s pharmacovigilance database. Healthcare professionals are advised to stop the use of all Gastrografin formulations. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.