Nigerian Public Alert 73: NAFDAC Notifies on WHO Alert on Substandard ACCUPAQUE (Iohexol), OMNIPAQUE (Iohexol) and VISIPAQUE (Iodixanol) in all WHO regions

Nigerian Public Alert 73: The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying Healthcare providers and the public of multiple batches of substandard ACCUPAQUE, OMNIPAQUE, and VISIPAQUE solutions for injection presented in 100 ml polypropylene containers identified in Ireland and reported to WHO by the Health Products Regulatory Authority (HPRA), Ireland, in March 2026.

A Class I quality defect was identified in specific batches of iodinated contrast media (Iohexol or Iodixanol) marketed under the brand names ACCUPAQUE, OMNIPAQUE, and VISIPAQUE, manufactured by GE HealthCare Ireland Limited.

The defect involves metallic particulate matter present on the inner surface of polypropylene (plastic) bottles. The manufacturer also confirmed the presence of a free metallic particulate within the finished product. This quality defect only affects batches supplied in 100 ml plastic containers. Batches supplied in glass containers are not affected.

The batches of these products affected have been supplied globally to multiple countries. Distribution primarily occurred at the hospital level, including facilities performing interventional radiology, cardiology procedures, and vascular surgery procedures.

Risk Statement

These products are injectable solutions for intra-arterial and intravenous use. The presence of particulate matter poses a safety risk, especially when injected intra-arterially, and can cause serious adverse events, including life-threatening embolic events.

To prevent patient harm, it is important to identify and remove the affected batches of Accupaque, Omnipaque, and Visipaque from clinical use.

Product Details

Omnipaque 350mg/ml and 300mg/ml injections are registered for use in Nigeria, NRN: B4-0328 and B4-0329, respectively, while Visipaque is not registered.

The details of the affected products are as follows;

Stated Manufacturer: GE Healthcare Ireland Limited

List of affected products and batches

Product Batch Expiry
26170256 OMNIPAQUE350 10x100PP 17253643 30-Jul-28
26180630 VISIPAQUE320 10x100PP 17244625 14-Aug-28
ACCUPAQUE (Iohexol) Batch Expiry
ACCUPAQUE 300 mg USB 1×100 ml 17333581 07-Nov-28
ACCUPAQUE 300 mg USB 10×100 ml 17321114 06-Aug-28
ACCUPAQUE 300 mg USB 10×100 ml 17270628 06-Aug-28
ACCUPAQUE 300 mg USB 10×100 ml 17329106 22-Oct-28
ACCUPAQUE 300 mg USB 10×100 ml 17334255 22-Oct-28
ACCUPAQUE 300 mg USB 10×100 ml 17356931 04-Sep-28
ACCUPAQUE 300 mg USB 10×100 ml 17356935 12-Oct-28
ACCUPAQUE 300 mg USB 10×100 ml 17366385 15-Nov-28
ACCUPAQUE 300 mg USB 10×100 ml 17370957 16-Nov-28
ACCUPAQUE 300 mg USB 10×100 ml 17298685 06-Aug-28
ACCUPAQUE 300 mg USB 10×100 ml 17333586 22-Oct-28
ACCUPAQUE 300 mg USB 10×100 ml 17366373 15-Nov-28
ACCUPAQUE 350 mg USB 10×100 ml 17089899 20-Jan-28
ACCUPAQUE 350 mg USB 10×100 ml 17260069 05-Aug-28
ACCUPAQUE 350 mg USB 10×100 ml 17302542 11-Aug-28
ACCUPAQUE 350 mg USB 10×100 ml 17302545 25-Jul-28
ACCUPAQUE 350 mg USB 10×100 ml 17370473 02-Dec-28
ACCUPAQUE 350 mg USB 10×100 ml 17370474 01-Dec-28
ACCUPAQUE 350 mg USB 10×100 ml 17238981 05-Aug-28
ACCUPAQUE 350 mg USB 10×100 ml 17312081 06-Aug-28
ACCUPAQUE 350 mg USB 10×100 ml 17318004 14-Oct-28
ACCUPAQUE 350 mg USB 10×100 ml 17340520 21-Oct-28
OMNIPAQUE (Iohexol) Batch Expiry
OMNIPAQUE 300 mg USB 1×100 ml 17339149 04-Sep-28
OMNIPAQUE 300 mg USB 1×100 ml 17359537 22-Oct-28
OMNIPAQUE 300 mg USB 1×100 ml 17271303 05-Aug-28
OMNIPAQUE 300 mg USB 10×100 ml 17334249 07-Sep-28
OMNIPAQUE 300 mg USB 10×100 ml 17350896 04-Sep-28
OMNIPAQUE 300 mg USB 10×100 ml 17353261 22-Oct-28
OMNIPAQUE 300 mg USB 10×100 ml 17371056 30-Nov-28
OMNIPAQUE 300 mg USB 10×100 ml 17305242 31-Aug-28
OMNIPAQUE 300 mg USB 10×100 ml 17305243 30-Sep-28
OMNIPAQUE 300 mg USB 10×100 ml 17318263 31-Aug-28
OMNIPAQUE 300 mg USB 10×100 ml 17258864 04-Aug-28
OMNIPAQUE 300 mg USB 10×100 ml 17378212 13-Nov-28
OMNIPAQUE 300 mg USB 10×100 ml 17349041 13-Nov-28
OMNIPAQUE 300 mg USB 10×100 ml 17262273 04-Aug-28
OMNIPAQUE 300 mg USB 10×100 ml 17320901 06-Aug-28
OMNIPAQUE 300 mg USB 10×100 ml 17374661 16-Nov-28
OMNIPAQUE 300 mg USB 10×100 ml 17366313 31-Jan-29
OMNIPAQUE 300 mg USB 10×100 ml 17370931 12-Oct-28
OMNIPAQUE 300 mg USB 10×100 ml 17291358 04-Aug-28
OMNIPAQUE 300 mg USB 10×100 ml 17300760 04-Sep-28
OMNIPAQUE 300 mg USB 10×100 ml 17379399 14-Nov-28
OMNIPAQUE 300 mg USB 10×100 ml 17325312 13-Sep-28
OMNIPAQUE 300 mg USB 10×100 ml 17327161 07-Dec-28
OMNIPAQUE 300 mg USB 10×100 ml 17404129 13-Dec-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17225029 03-Sep-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17265376 03-Oct-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17270885 10-Sep-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17292246 04-Oct-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17301805 18-Oct-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17301807 07-Sep-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17301810 20-Oct-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17304992 05-Oct-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17304993 19-Oct-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17304996 25-Nov-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17321225 08-Sep-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17333589 24-Nov-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17333611 26-Nov-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17333613 23-Nov-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17357000 05-Dec-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17366399 14-Dec-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17376486 14-Dec-28
OMNIPAQUE 300mgI/ml USB 10×100 ml 17404114 06-Dec-28
OMNIPAQUE 350 mg USB 1×100 ml 17238983 26-Jul-28
OMNIPAQUE 350 mg USB 1×100 ml 17277327 11-Aug-28
OMNIPAQUE 350 mg USB 1×100 ml 17322643 14-Oct-28
OMNIPAQUE 350 mg USB 1×100 ml 17271306 11-Aug-28
OMNIPAQUE 350 mg USB 1×100 ml 17270328 26-Jul-28
OMNIPAQUE 350 mg USB 1×100 ml 17277326 06-Aug-28
OMNIPAQUE 350 mg USB 1×100 ml 17370479 21-Oct-28
OMNIPAQUE 350 mg USB 1×100 ml 17370480 21-Oct-28
OMNIPAQUE 350 mg USB 1×100 ml 17407025 04-Dec-28
OMNIPAQUE 350 mg USB 1×100 ml 17301796 08-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17277089 11-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17351100 07-Sep-28
OMNIPAQUE 350 mg USB 10×100 ml 17320944 25-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17411626 20-Nov-28
OMNIPAQUE 350 mg USB 10×100 ml 17332846 07-Sep-28
OMNIPAQUE 350 mg USB 10×100 ml 17238980 26-Jul-28
OMNIPAQUE 350 mg USB 10×100 ml 17277322 30-Jul-28
OMNIPAQUE 350 mg USB 10×100 ml 17298718 07-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17361175 01-Dec-28
OMNIPAQUE 350 mg USB 10×100 ml 17379390 25-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17429790 11-Dec-28
OMNIPAQUE 350 mg USB 10×100 ml 17277208 25-Jul-28
OMNIPAQUE 350 mg USB 10×100 ml 17340558 30-Nov-28
OMNIPAQUE 350 mg USB 10×100 ml 17327354 14-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17324090 01-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17361386 01-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17364400 01-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17364401 01-Nov-28
OMNIPAQUE 350 mg USB 10×100 ml 17275275 30-Sep-28
OMNIPAQUE 350 mg USB 10×100 ml 17227949 31-Jul-28
OMNIPAQUE 350 mg USB 10×100 ml 17340534 31-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17361385 30-Nov-28
OMNIPAQUE 350 mg USB 10×100 ml 17403686 31-Dec-28
OMNIPAQUE 350 mg USB 10×100 ml 17291368 11-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17349069 01-Dec-28
OMNIPAQUE 350 mg USB 10×100 ml 17413362 15-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17258866 11-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17378255 20-Nov-28
OMNIPAQUE 350 mg USB 10×100 ml 17212392 05-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17349047 21-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17294798 06-Sep-28
OMNIPAQUE 350 mg USB 10×100 ml 17358213 14-Nov-28
OMNIPAQUE 350 mg USB 10×100 ml 17396721 03-Jan-29
OMNIPAQUE 350 mg USB 10×100 ml 17340557 11-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17367331 24-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17364593 14-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17291310 30-Jul-28
OMNIPAQUE 350 mg USB 10×100 ml 17352078 13-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17388194 21-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17368323 20-Nov-28
OMNIPAQUE 350 mg USB 10×100 ml 17244048 25-Jul-28
OMNIPAQUE 350 mg USB 10×100 ml 17374668 02-Dec-28
OMNIPAQUE 350 mg USB 10×100 ml 17344032 06-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17306297 23-Jul-28
OMNIPAQUE 350 mg USB 10×100 ml 17308416 26-Jul-28
OMNIPAQUE 350 mg USB 10×100 ml 17314055 05-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17328722 12-Nov-28
OMNIPAQUE 350 mg USB 10×100 ml 17358222 12-Dec-28
OMNIPAQUE 350 mg USB 10×100 ml 17376107 13-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17409644 10-Nov-28
OMNIPAQUE 350 mg USB 10×100 ml 17433391 17-Dec-28
OMNIPAQUE 350 mg USB 10×100 ml 17277315 31-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17312303 31-Jul-28
OMNIPAQUE 350 mg USB 10×100 ml 17323704 31-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17370063 30-Sep-28
OMNIPAQUE 350 mg USB 10×100 ml 17407055 31-Dec-28
OMNIPAQUE 350 mg USB 10×100 ml 17425028 31-Dec-28
OMNIPAQUE 350 mg USB 10×100 ml 17359070 17-Sep-28
OMNIPAQUE 350 mg USB 10×100 ml 17402891 30-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17402903 02-Nov-28
OMNIPAQUE 350 mg USB 10×100 ml 17406203 01-Nov-28
OMNIPAQUE 350 mg USB 10×100 ml 17417180 25-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17296065 07-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17201254 06-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17305630 30-Jul-28
OMNIPAQUE 350 mg USB 10×100 ml 17370936 14-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17383109 15-Oct-28
OMNIPAQUE 350 mg USB 10×100 ml 17239721 30-Aug-28
OMNIPAQUE 350 mg USB 10×100 ml 17241442 06-Sep-28
OMNIPAQUE 350 mg USB 10x100ml 17183380 31-Jul-28
OMNIPAQUE 350 mg USB 10x100ml 17319894 07-Aug-28
OMNIPAQUE 350 mg U 10×100 ml 17253638 07-Aug-28
OMNIPAQUE 350mgI/ml USB 10×100 ml 17306628 05-Sep-28
OMNIPAQUE 350mgI/ml USB 10×100 ml 17333197 10-Dec-28
OMNIPAQUE 350mgI/ml USB 10×100 ml 17333198 17-Nov-28
OMNIPAQUE 350mgI/ml USB 10×100 ml 17396945 18-Dec-28
OMNIPAQUE 350mgI/ml USB 10×100 ml 17396948 22-Dec-28
OMNIPAQUE 350mgI/ml USB 10×100 ml 17396953 11-Jan-29
OMNIPAQUE 350mgI/ml USB 10×100 ml 17396956 09-Jan-29
OMNIPAQUE 350mgI/ml USB 10×100 ml 17423503 01-Jan-29
OMNIPAQUE 350mgI/ml USB 10×100 ml 17423525 03-Jan-29
OMNIPAQUE 350mgI/ml USB 10×100 ml 17426429 01-Jan-29
OMNIPAQUE 350mgI/ml USB 10×100 ml 17426440 04-Jan-29
OMNIPAQUE 350mgI/ml USB 10×100 ml 17431310 11-Jan-29
OMNIPAQUE 647 mg USB 10×100 ml 17296089 06-Aug-28
OMNIPAQUE 647 mg USB 10×100 ml 17322376 22-Oct-28
OMNIPAQUE 647 mg USB 10×100 ml 17363927 13-Nov-28
OMNIPAQUE 755 mg USB 10×100 ml 17247369 06-Aug-28
VISIPAQUE (Iodixanol) Batch Expiry
VISIPAQUE 320 mg USB 1×100 ml 17270129 26-Jul-28
VISIPAQUE 320 mg USB 1×100 ml 17363725 05-Dec-28
VISIPAQUE 320 mg USB 1×100 ml 17385132 13-Dec-28
VISIPAQUE 320 mg USB 1×100 ml 17292643 14-Aug-28
VISIPAQUE 320 mg USB 1×100 ml 17305012 25-Jul-28
VISIPAQUE 320 mg USB 1×100 ml 17271300 25-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17305010 13-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17320967 15-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17338638 15-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17306843 25-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17336632 05-Dec-28
VISIPAQUE 320 mg USB 10×100 ml 17353211 25-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17247383 14-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17331540 25-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17299098 22-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17264297 25-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17325742 22-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17338633 25-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17314000 25-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17264301 15-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17264302 01-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17302277 01-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17323156 01-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17302289 31-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17302290 31-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17321866 31-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17264005 25-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17291370 25-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17349086 05-Dec-28
VISIPAQUE 320 mg USB 10×100 ml 17230467 14-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17350682 22-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17318726 13-Sep-28
VISIPAQUE 320 mg USB 10×100 ml 17330329 22-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17437211 13-Dec-28
VISIPAQUE 320 mg USB 10×100 ml 17264311 13-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17291421 22-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17201256 13-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17230526 15-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17320931 15-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17320932 22-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17320933 19-Sep-28
VISIPAQUE 320 mg USB 10×100 ml 17422210 13-Dec-28
VISIPAQUE 320 mg USB 10×100 ml 17275012 22-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17303283 22-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17341274 22-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17363903 05-Dec-28
VISIPAQUE 320 mg USB 10×100 ml 17291424 22-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17278120 22-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17358219 05-Dec-28
VISIPAQUE 320 mg USB 10×100 ml 17415131 05-Dec-28
VISIPAQUE 320 mg USB 10×100 ml 17300762 25-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17272574 14-Sep-28
VISIPAQUE 320 mg U 10×100 ml 17312861 15-Aug-28
VISIPAQUE 320 mg U 10×100 ml 17312864 19-Sep-28
VISIPAQUE 320 mg USB 10×100 ml 17244652 26-Jul-28
VISIPAQUE 320 mg USB 10×100 ml 17303308 15-Aug-28
VISIPAQUE 320 mg USB 10×100 ml 17312888 19-Sep-28
VISIPAQUE 320MG 100 ML USB 17303269 15-Aug-28
VISIPAQUE 320MG 100 ML USB 17312884 22-Aug-28
VISIPAQUE 320MG 100 ML USB 17388227 05-Dec-28
VISIPAQUE 320mg USB 1x100ml 32gI 17393760 14-Aug-28
VISIPAQUE 320mg USB 1x100ml 32gI 17393761 12-Aug-28
VISIPAQUE 320mg USB 1x100ml 32gI 17393764 12-Aug-28
VISIPAQUE 320mg USB 1x100ml 32gI 17393765 21-Aug-28
VISIPAQUE 320mg USB 1x100ml 32gI 17403780 22-Aug-28
VISIPAQUE 320mg USB 1x100ml 32gI 17421451 19-Aug-28
VISIPAQUE 320mg USB 1x100ml 32gI 17425290 20-Sep-28
VISIPAQUE 320mg USB 1x100ml 32gI 17425291 10-Oct-28
VISIPAQUE 320mg USB 1x100ml 32gI 17425292 20-Sep-28
VISIPAQUE 320mg USB 1x100ml 32gI 17428130 19-Sep-28
VISIPAQUE 320mg USB 1x100ml 32gI 17428132 19-Sep-28
VISIPAQUE 320mg USB 1x100ml 32gI 17432322 20-Sep-28
VISIPAQUE 320mg USB 1x100ml 32gI 17444560 09-Oct-28

All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the substandard products if found within the zones and states.

Importers, Distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of substandard products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng

Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med- safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng

 

PositiveNaija Nigerian Public Alert

The Nigerian Public Alert 73 initiative by PositiveNaija is aimed at keeping Nigerians well-informed particularly in regards to their safety and development. For future developments on this news, kindly follow up through the official communication channels of the reporting/regulatory authority.

We publish these alerts for free and will appreciate your support for our work – Moniepoint – 9064503292 – United Green Stars Worldwide Limited (kindly describe as “donation or gift”). Thank you.

Subscribe
Notify of
guest

0 Comments
Newest
Oldest Most Voted
Inline Feedbacks
View all comments