RECORDS ARE PUBLISHED REGULATORY ACTIONS. FIELDS THE ISSUING AUTHORITY DID NOT PUBLISH ARE MARKED AS NOT STATED, NEVER FILLED IN.
Drug Eye AfricaNational Actions, Continental Reach
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Register / South Africa / DEA-ZA-2026-0061
South African Health Products Regulatory Authority · South Africa
DEA-ZA-2026-0061
Tier 1 · Regulator-publishedUnclassifiedسحبStatus · 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
المستحضر
Contrast media (iohexol)
INN / active substance
iohexol
Dosage form
Not stated by the issuing authority
Strength
Not stated by the issuing authority
الشركة المصنعة
Not stated by the issuing authority
Manufacturer country
Not stated by the issuing authority
MAH or importer
Not stated by the issuing authority
أرقام التشغيلات
Not published with the notice
تواريخ انتهاء الصلاحية
Not published with the notice
Action type
سحب
التصنيف
Not stated by the issuing authority
Indicative severity
Not assessed by Drug Eye Africa
Defect category
دون المواصفات — السبب غير مذكور
Product type
دواء
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
نص الإخطار
Not captured. The notice itself is linked below.
الحالة
سارٍ
Superseded by
Not superseded. This is the current version.
Version
1

Provenance

Verification tier 1

Where this record came from, and what is held to show it.

Primary source
https://www.sahpra.org.za/document/omnipaque-iohexol-anhydrous/
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Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
5dcdd77db450e0723aad15e97bb28cdb5004080507d1556dffeb145564af03d8
SHA-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

Related actions elsewhere

Open the event view →
ReferenceDateCountryProductBatchesActionClassSource
DEA-XXX-2026-000107 May 2026XXACCUPAQUE (Iohexol), OMNIPAQUE (Iohexol) and VISIPAQUE (Iodixanol)none publishedPublic warningUnclassifiedTier 1 · Regulator-published
DEA-KE-2026-000907 May 2026KEOmnipaque 350mg
GE HealthCare, Ireland		17212392RecallUnclassifiedTier 1 · Regulator-published
DEA-EG-2026-0025Apr 2026EGOmnipaque 300 mg/ml
GE healthcare Ireland		17350896 · 17334249RecallClass IITier 1 · Regulator-published
Cite this record
Drug Eye Africa (2026). DEA-ZA-2026-0061: Contrast media (iohexol) — سحب, South African Health Products Regulatory Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/za/2026/dea-za-2026-0061

Version 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.

This record as data

/api/v1/notices/DEA-ZA-2026-0061