Egyptian Drug Authority · Egypt
DEA-EG-2026-0025
Tier 1 · Regulator-publishedClass IIRecallStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- Periodic report no.(25) For 2026
- Date issued
- Apr 2026
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Product
- Omnipaque 300 mg/ml
- INN / active substance
- Not stated by the issuing authority
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Manufacturer
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- Not published with the notice
- Expiry dates
- Not published with the notice
- Action type
- Recall
- Classification
- Class II as issued
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Not stated by the issuing authority
- Product type
- Not stated by the issuing authority
- ATC code
- Not stated by the issuing authority
- Affected markets
- Egypt — no market beyond the issuing country was named on the notice
- Cross-border event
- Substandard iohexol contrast media
- Notice text
- Omnipaque 300 mg/ml (100 ml)
GE healthcare Ireland
الكان ميديكال
17334249و17350896
9/28
وذلـــك لكـــون التشغيلات الموضحة بعاليه
من المســـتحضرغير مطابقة للمواصفات
المنصوص عليها من قبل هيئة الدواء
وقف تداول و ضبط وتحريز التشغيلات
من المستحضر الصادر لها عدم مطابقة
في حالة الشك في المستحضر الصيدلى يتم
الرجوع إلى هيئة الدواء المصرية سواء
بالإتصال بالخط الساخن 15301او الموقع
الإلكترونى الخاص بالهيئة.
أبريل 2026
اسم المستحضر
رقم التشغيلات
سبب التحذير
الإجراءات
التصحيحية
نصائح
للمستهلكين
منشور
سحب
الشركة المستوردة
هذا التنبية خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق على
تداول المستحضر بشكل عام
تاريخ الانتهاء
الشركة المصنعةOriginal language: ar
- Notice text in English
- Notice. Omnipaque 300 mg/ml (100 ml), of GE Healthcare Ireland, agent Alkan Medical, batches 17334249 and 17350896, expiry 9/28, the batches set out above not conforming to the specifications laid down by the Authority.Machine translation, produced by Drug Eye Africa and not checked by the issuing authority. The authority stated only the text above it.
- Status
- Active
- Superseded by
- Not superseded. This is the current version.
- Version
- 3
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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 897fb63add33d23992872bc59dae6b6581de6d4a65fdd64f1ce8210faadce3b5SHA-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 20:49:14 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-KE-2026-0009 | 07 May 2026 | KE | Omnipaque 350mg GE HealthCare, Ireland | 17212392 | Recall | Unclassified | Tier 1 · Regulator-published |
| DEA-ZA-2026-0061 | 20 Apr 2026 | ZA | Contrast media (iohexol) | none published | Recall | Unclassified | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2026). DEA-EG-2026-0025: Omnipaque 300 mg/ml — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0025Version history
—No version history recorded for this record.
—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.