Egyptian Drug Authority · Egypt
DEA-EG-2025-0089
Tier 1 · Regulator-publishedUnclassifiedPublic warningStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- periodic report no(89) For 2025
- Date issued
- Nov 2025
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Product
- Rhophylac300 Human anti-D (RH)immunoglobulin
- 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
- P100341349 · P100351348
- 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
- Rhophylac300 Human anti-D
(RH)immunoglobulin
2S PHARMA
P100341349-P100351348
طبقاَ لإفادة الشركة حول وجود عبوات
مجهولة المصدر من الصنف المذكور
سحب ووقف تداول وتحريز العبوات
مجهول المصدر من المستحضر المذكور
في حالة الشك في المستحضر الصيدلى يتم
الرجوع إلى هيئة الدواء المصرية سواء
بالإتصال بالخط الساخن 15301او الموقع
الإلكترونى الخاص بالهيئة.
يمكنك الضغط علىالرابطللاطلاععلى
الصور الخاصة بالمستحضر المقلد.
نوفمبر 2025
اسم المستحضر
سبب التحذير
الإجراءات
التصحيحية
نصائح
للمستهلكين
منشور
غش تجاري
هذا التنبية خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق على
تداول المستحضر بشكل عام
رقم التشغيلة
الشركة المستوردةOriginal language: ar
- Notice text in English
- Recall, halt of circulation and seizure. Rhophylac 300 human anti-D (Rh) immunoglobulin, of 2S Pharma, batches P100341349 and P100351348. The company has reported packs of unknown origin, and the packs of unknown origin are to be recalled, withdrawn from circulation and seized.Machine translation, produced by Drug Eye Africa and not checked by the issuing authority.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- Superseded by
- Not superseded.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
- d43c1262144a9b2a96b2b281b87d65380d6c04489e0a1fa2712c8a41a98b8c32SHA-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 20:48:01 UTC
Cite this record
Drug Eye Africa (2025). DEA-EG-2025-0089: Rhophylac300 Human anti-D (RH)immunoglobulin — Public warning, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2025/dea-eg-2025-0089Version 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.