Pharmacy and Poisons Board · Kenya
DEA-KE-2026-0009
Tier 1 · Regulator-publishedUnclassifiedRecallStatus · active
- Issuing authority
- Pharmacy and Poisons Board (PPB)
- Authority reference
- REC/2026/009
- Date issued
- 07 May 2026Format ambiguous in the source; resolved to 2026-05-07 by the table's chronological order.
- Recorded by us
- 2026-09-06 17:27:54 UTC
- Product
- Omnipaque 350mg
- INN / active substance
- Iohexol
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Manufacturer
- GE HealthCare, Ireland
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- 17212392
- Expiry dates
- Not published with the notice
- Action type
- Recall
- Classification
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Not stated by the issuing authority
- Product type
- Medicine
- ATC code
- Not stated by the issuing authority
- Affected markets
- Kenya — no market beyond the issuing country was named on the notice
- Cross-border event
- Substandard iohexol contrast media
- Notice text
- Presence of dark particlesOriginal language: en
- Status
- Active
- Superseded by
- Not superseded. This is the current version.
- Version
- 7
Where this record came from, and what is held to show it.
- Primary source
- https://web.pharmacyboardkenya.org/omnipaque-350mg/
- Copy of the source
- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn. Not yet published at an address you can open.Ask us for it and check it against the fingerprint below.
- Fingerprint
- 6133c9cbbda563cba75cf180af34238279ddc0ca9c81f6826fb01faa77ee30b2SHA-256 of the copy held. Any file that produces this number is that copy, byte for byte; any file that does not is a different document.
- Copy taken
- 2026-09-06 22:58:31 UTC
| Reference | Date | Ctry | Product | Batches | Action | Class | Source |
|---|---|---|---|---|---|---|---|
| DEA-XXX-2026-0001 | 07 May 2026 | XX | ACCUPAQUE (Iohexol), OMNIPAQUE (Iohexol) and VISIPAQUE (Iodixanol) | none published | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-ZA-2026-0061 | 20 Apr 2026 | ZA | Contrast media (iohexol) | none published | Recall | Unclassified | Tier 1 · Regulator-published |
| DEA-EG-2026-0025 | Apr 2026 | EG | Omnipaque 300 mg/ml | none published | Recall | Class II | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2026). DEA-KE-2026-0009: Omnipaque 350mg — Recall, Pharmacy and Poisons Board. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/ke/2026/dea-ke-2026-0009Version history
v1Created from the PPB register. No corrections. (correction)
—Corrections appear here and in the site-wide log. Records are superseded, never deleted.
Verification
Tier 1 — Published by the issuing regulator on its own channel and captured by Drug Eye Africa, with the source document archived.
Indexing
This record is indexable: it is dated, names a product, and carries either a batch number or a stated reason.