27 Apr Urografin (Meglumine amidotrizoate + Sodium amidotrizoate solution 0.76 g/mL)
| Company name & Address: | Product strength | registration number | Batch number(s) | Expiry date | Pack size | First release date | Re-call Classification | Recall date |
| Cipla Medpro (Pty) Ltd
Building 2 Junxion Park 10 Elephant Lane Century City South Africa 7441 |
Urografin 30% |
F/28/0606 | MA04VPS MA04V7D
MA04SJ4 |
30/04/2030
30/04/2030 30/09/2029 |
250 ml | June 2025
|
Class II Type B | 06.Mar.2026 |
|
Urografin 60% |
H/28/2843 |
MA04R29 |
31/08/2029 |
250 ml |
June 2025
|
Class II Type B |
06.Mar.2026 |
|
|
Urografin 76% |
H/28/2844 |
MA04SRF MA04X07 |
30/09/2029 30/09/2029 |
250 ml |
June 2025 |
Class II Type B |
06.Mar.2026 |
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.