RECORDS ARE PUBLISHED REGULATORY ACTIONS. FIELDS THE ISSUING AUTHORITY DID NOT PUBLISH ARE MARKED AS NOT STATED, NEVER FILLED IN.
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Register / Egypt / DEA-EG-2025-0043
Egyptian Drug Authority · Egypt
DEA-EG-2025-0043
Tier 1 · Regulator-publishedUnclassifiedتحذير للجمهورStatus · 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
المستحضر
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
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
P100351349- · P100500356 · P100351349- · P100500356 · P100351349
تواريخ انتهاء الصلاحية
Not published with the notice
Action type
تحذير للجمهور
التصنيف
Not stated by the issuing authority
Indicative severity
Not assessed by Drug Eye Africa
Defect category
مغشوش
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
نص الإخطار
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 عام
Original language: ar
نص الإخطار بالإنجليزية
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.
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Superseded by
Not superseded.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://edaegypt.gov.eg/media/orendbwj/%D8%BA%D8%B4-%D8%AA%D8%AC%D8%A7%D8%B1%D9%8A-%D9%86%D8%B4%D8%B1-%D8%B1%D9%88%D9%81%D9%8A%D9%84%D8%A7%D9%83.pdf
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
0d234603eaabb8449f1691046c27725c2254daaa1b68bcd2d68356511fc7bb22
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
2026-09-06 20:46:29 UTC

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Cite this record
Drug Eye Africa (2025). DEA-EG-2025-0043: RHOPHYLAC 300 — تحذير للجمهور, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2025/dea-eg-2025-0043

Version history

v1Manufacturer removed: the notice describes the packaging as counterfeit (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-EG-2025-0043