Register / South Africa / DEA-ZA-2026-0061
South African Health Products Regulatory Authority · South Africa
DEA-ZA-2026-0061
Tier 1 · Regulator-publishedUnclassifiedRecolhaStatus · active
- Issuing authority
- South African Health Products Regulatory Authority (SAHPRA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 20 Apr 2026
- Recorded by us
- 2026-09-06 17:27:54 UTC
- Produto
- Contrast media (iohexol)
- INN / active substance
- iohexol
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Fabricante
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Números de lote
- Not published with the notice
- Prazos de validade
- Not published with the notice
- Action type
- Recolha
- Classificação
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Fora do padrão — causa não indicada
- Product type
- Medicamento
- ATC code
- Not stated by the issuing authority
- Affected markets
- South Africa — no market beyond the issuing country was named on the notice
- Cross-border event
- Substandard iohexol contrast media
- Texto do aviso
- Not captured. The notice itself is linked below.
- Estado
- Em vigor
- Superseded by
- Not superseded. This is the current version.
- Version
- 1
Where this record came from, and what is held to show it.
- 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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 5dcdd77db450e0723aad15e97bb28cdb5004080507d1556dffeb145564af03d8SHA-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
- 2026-09-09 18:58:05 UTC
| Reference | Date | Country | 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-KE-2026-0009 | 07 May 2026 | KE | Omnipaque 350mg GE HealthCare, Ireland | 17212392 | Recall | Unclassified | Tier 1 · Regulator-published |
| DEA-EG-2026-0025 | Apr 2026 | EG | Omnipaque 300 mg/ml GE healthcare Ireland | 17350896 · 17334249 | Recall | Class II | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2026). DEA-ZA-2026-0061: Contrast media (iohexol) — Recolha, South African Health Products Regulatory Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/za/2026/dea-za-2026-0061Version history
v1Created from the SAHPRA 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.