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-2025-0048
Egyptian Drug Authority · Egypt
DEA-EG-2025-0048
Tier 1 · Regulator-publishedUnclassifiedتحذير للجمهورStatus · active
Issuing authority
Egyptian Drug Authority (EDA)
Authority reference
periodic report no(48) For 2025
Date issued
Jul 2025
Recorded by us
2026-09-06 19:45:29 UTC
المستحضر
Betadine antiseptic solution
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
P5409013
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
Betadine antiseptic solution P5409013 شركة النيل للادوية و الصناعات الكيماوية 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 التشغيلة 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 Betadine antiseptic solution, of the Nile Company for Pharmaceuticals and Chemical Industries, batch P5409013, 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Superseded by
Not superseded.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/whrm3yfu/%D8%BA%D8%B4-%D8%AA%D8%AC%D8%A7%D8%B1%D9%8A-%D9%86%D8%B4%D8%B1-%D8%A8%D9%8A%D8%AA%D8%A7%D8%AF%D9%8A%D9%86.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
12a0ca6c8ae562c41555cc9ab40c862b0c8787f5f7fd67f4df5d3e5c02cfe901
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 20:46:39 UTC

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Cite this record
Drug Eye Africa (2025). DEA-EG-2025-0048: Betadine antiseptic solution — تحذير للجمهور, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2025/dea-eg-2025-0048

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-2025-0048