30 Apr Omnipaque (Iohexol anhydrous)
| Company name & Address: | Product strength | registration number | Batch number(s) | Expiry date | Pack size | First release date | Re-call Classification | Recall date |
| Ge Healthcare (Pty) Ltd
Office Suite BOG Ground Floor Level, Building B Stoneridge Office Park 8 Greenstone Place, Greenstone Hill Johannesburg, Gauteng South Africa, 1609 |
Omnipaque 300 mg/100 ml |
X/28/80 |
17262906 17314099 |
August 2028 August 2028 |
100 ml |
12 December 2025 12 December 2025 |
Class II Type B |
20.April.2026 |
| Omnipaque 350 mg/ml 100 ml | X/28/81 | 17238977
17298734 17313028 17376110 |
August 2028
August 2028 September 2028 December 2028 |
100 ml | 29 October 2025
12 December 2025 28 January 2026 N/A |
Class II Type B | 20.April.2026 |
Brief description of the problem (reason for recall)
This recall is initiated because GE HealthCare has become aware that certain 100 ml bottles of Omnipaque (see product details above) may have particles adhered to the polymer bottles. If these particles become dislodged and are not recognized before injection, they may pose a patient safety concern.
Advise for health professionals and distributors:
Please check your stock immediately. If you have any product from the batches listed above in your inventory, please discontinue use, stop distribution and quarantine the product immediately. Please return affected batch(es) of Products listed above to UPD (United Pharmaceutical Distributors) or your supplying
wholesaler with immediate effect for credit. For further product information, please call GE Healthcare (Pty) Ltd on +27 83 999 8067 or +27 67 596 7296.
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.