Egyptian Drug Authority · Egypt
DEA-EG-2026-0043
Tier 1 · Regulator-publishedUnclassifiedPublic warningStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- Periodic report no.(43) For 2026
- Date issued
- May 2026
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Product
- Danset 8mg/4ml
- 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
- All batchesThe authority recalled every batch of this product, so no list was published.
- 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
- Danset 8 mg \ 4 ml
رقم التشغيلات
تداول عبوات مجهولة المصدرمن الصنف الموضح
بعاليه و ذلك طبقا لما ورد الينا من شركة adwia
صاحبة المستحضر حيث افادت ان العبوات
بالاختلافات الموضحة مقلدة و لم يتم تصنيعها
بمعرفتهم
وقف تداول و ضبط وتحريز المستحضر
المغشوش
في حالة الشك في المستحضر الصيدلى يتم الرجوع
الى هيئة الدواء المصرية سواء بالإتصال بالخط
الساخن 15301او الموقع الإلكترونى الخاص
بالهيئة.
يمكن الضغط على الرابطللإطلاع على الصور
الخاصة بالمستحضر المقلد.
مايو 2026
منشور
غش تجاري
اسم المستحضر
الشركة صاحبة المستحضر
سبب التحذير
الإجراءات
التصحيحية
نصائح
للمستهلكين
هذا التنبيه خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق على تداول
المستحضر بشكل عام
الشركة المصنعة المدونة
علي العبوات
Adwia
Inad pharma
20240150و20240153و20240154و20240152
و جميع التشغيلات الاخري التي تحمل نفس الاختلافات الظاهرية
الموضحةOriginal language: ar
- Notice text in English
- Notice. Circulation of packs of unknown origin of Danset 8 mg/4 ml, according to what Adwia, which owns the product, has reported to the Authority, the packs showing the differences described not being theirs. The batch numbers are not carried in the extracted text.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
- 3
Where this record came from, and what is held to show it.
- Primary source
- https://www.edaegypt.gov.eg/media/5gvbs3mc/%D8%BA%D8%B4-%D8%AA%D8%AC%D8%A7%D8%B1%D9%8A-danset.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
- 9f127ce5d45c976688bf3dff80bb49dcca166229904f81aebc056e333ec0cf29SHA-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 20:49:50 UTC
Cite this record
Drug Eye Africa (2026). DEA-EG-2026-0043: Danset 8mg/4ml — Public warning, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0043Version 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.