Medicine Quality Alert: Class II Medicines Recall of OMNIPAQUE 350MG 10X100ML BATCH 17212392
PPB has mandated Surgipharm to recall Omnipaque 350mg 10X100ml BN 17212392.
From: Pharmacy and Poisons Board
Published: 30th April 2026
Recall Reference Number: REC/2026/007
Recall Classification: Class II
Recall Level: Retail/Facility Level
Manufacturer: GE HealthCare
LTR: Imperial Surgipham Limited
Product name: Omnipaque 350mg
Active Pharmaceutical Ingredient: Iohexol
Affected counties: All
Affected Batches
S/N | Batch No | Mfg Date | Exp Date | Pack Size |
1. | 17212392 | 09/2025 | 08/2028 | 100ml |
Brief description of the problem
Mandatory recall has been initiated because an adhered particle was noted on the inner wall / in-wall of the Unique Soft Bottle (USB) for the semi-finished product. The presence of dark particles, appearing to be embedded within the product container, poses an unacceptable risk to product quality, safety, and integrity.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing, or use of Omnipaque Batch 17212392, immediately, and contact Surgipharm to arrange return.
Action for patients and caregivers
Patients are advised to talk to their healthcare professional if they have the above batch of Omnipaque Batch 17212392.
Further Information
For any inquiries on consignments, please contact Surgipharm Ltd by email at info@surgipharm.com OR drugsafety@surgipharm.com via telephone at 0722204707, 0734224228.
Promptly report any case/s of suspected substandard and falsified products or adverse reactions or insufficient control of symptoms to the nearest healthcare facility or the Pharmacy and Poisons Board through the following channels:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
- Mobile application: mPvERS both Android and iOS
For any further enquiries and feedback on the product recall, contact the post-marketing surveillance unit at the Pharmacy and Poisons Board via email at pms@ppb.go.ke
Download Document
Medicine Quality Alert: Class II Medicines Recall of OMNIPAQUE 350MG 10X100ML BATCH 17212392