Egyptian Drug Authority · Egypt
DEA-EG-2025-0094
Tier 1 · Regulator-publishedClass IIRecallStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- periodic report no(94) For 2025
- Date issued
- Dec 2025
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Product
- Epifasi 5000 IU ampoule
- 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
- 2505156 · 250338
- 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
- Not linked to a cross-border event
- Notice text
- Epifasi 5000 IU ampoule
2505156
250338
Eipico
صدور عدم مطابقة للمذيب الذي يحمل
رقم تشغيلة 250338المتواجد بالعبوة التي
تحمل رقم التشغيلة 2505156من معامل
هيئة الدواء المصرية
وقف تداول و ضبط وتحريزالتشغيلةمن
المستحضر الصادر للمذيب المتواجد
بداخل عبوتها عدم مطابقة
في حالة الشك في المستحضر الصيدلى يتم
الرجوع إلى هيئة الدواء المصرية سواء
بالإتصال بالخط الساخن 15301او الموقع
الإلكترونى الخاص بالهيئة.
ديسمبر2025
اسم المستحضر
رقم التشغيلة الخاص
بالمستحضر
سبب التحذير
الإجراءات
التصحيحية
نصائح
للمستهلكين
منشور
سحب
الشركة المصنعة
هذا التنبية خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق على
تداول المستحضر بشكل عام
رقم التشغيلة الخاص
بالمذيبOriginal language: ar
- Notice text in English
- Halt of circulation. Epifasi 5000 IU ampoule, of EIPICO, batch 2505156. A finding of non-conformity has been issued by the Egyptian Drug Authority laboratories for the solvent bearing batch number 250338 contained in the pack bearing batch number 2505156.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- Superseded by
- Not superseded.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
- 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
- d68b5833ef0c8d2888e28b4de40c4e95e3a97c359007038e2c1923b647a0a72bSHA-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 20:48:11 UTC
Cite this record
Drug Eye Africa (2025). DEA-EG-2025-0094: Epifasi 5000 IU ampoule — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2025/dea-eg-2025-0094Version 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.