Egyptian Drug Authority · Egypt
DEA-EG-2025-0043
Tier 1 · Regulator-publishedUnclassifiedPublic warningStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- periodic report no(43) For 2025
- Date issued
- Jul 2025
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Product
- RHOPHYLAC 300
- 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
- Public warning
- 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
- 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
- Rhophylac 300Human anti-D (RH)
immunoglobulin
P100500356-P100351349
2s pharma group
طبقا لإفادة الشركة حول وجود عبوات
مقلدةمن الصنف المذكور
وقف تداول و ضبط وتحريز المستحضر
المقلد
في حالة الشك في المستحضر الصيدلى
يتم الرجوع الى هيئة الدواء المصرية
سواء بالإتصال بالخط الساخن 15301او
الموقع الإلكترونى الخاص بالهيئة.
يمكن الضغط على الرابطللإطلاععلى
الصور الخاصة بالمستحضر المقلد.
يوليو 2025
منشور
غش تجاري
اسم المستحضر
الشركة المنتجة
رقم التشغيلات
سبب التحذير
الإجراءات
التصحيحية
نصائح
للمستهلكين
هذا التنبيه خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق على
تداول المستحضر بشكل عامOriginal language: ar
- Notice text in English
- Notice. Counterfeit packs of Rhophylac 300 human anti-D (Rh) immunoglobulin, of 2S Pharma Group, batches P100500356 and P100351349, have been reported by the company. Circulation is to stop and the counterfeit product is to be impounded and seized.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- Superseded by
- Not superseded.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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 0d234603eaabb8449f1691046c27725c2254daaa1b68bcd2d68356511fc7bb22SHA-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 20:46:29 UTC
Cite this record
Drug Eye Africa (2025). DEA-EG-2025-0043: RHOPHYLAC 300 — Public warning, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2025/dea-eg-2025-0043Version 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.