Egyptian Drug Authority · Egypt
DEA-EG-2025-0080
Tier 1 · Regulator-publishedUnclassifiedMise en garde au publicStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- periodic report no(80) For 2025
- Date issued
- Oct 2025
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Produit
- Zithrokan capsule
- INN / active substance
- Not stated by the issuing authority
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Fabricant
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Numéros de lot
- 407
- Dates de péremption
- Not published with the notice
- Action type
- Mise en garde au public
- Classification
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Falsifié
- 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
- Texte de l’avis
- Zithrokan capsule
Hikma Pharma
407
طبقا لإفادة الشركة صاحبة المستحضر
حول وجود عبوات مقلدة من الصنف
المذكور
وقف تداول و ضبط وتحريز المستحضر
مجهول المصدر
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.
أكتوبر 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 عامOriginal language: ar
- Texte de l’avis en anglais
- Notice. The company that owns the product has reported counterfeit packs of Zithrokan capsules, of Hikma Pharma, batch 407. Circulation is to stop and the product of unknown origin 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.
- Statut
- En vigueur
- Superseded by
- Not superseded. This is the current version.
- Version
- 1
Where this record came from, and what is held to show it.
- Primary source
- https://edaegypt.gov.eg/media/uhrlmhus/%D8%BA%D8%B4-%D8%AA%D8%AC%D8%A7%D8%B1%D9%8A-%D9%86%D8%B4%D8%B1zithrokan-1632.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
- 3140854d57eaad04e833581041aa7ac226d27b4d01a1e00461588e1d2f36e349SHA-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 20:47:43 UTC
| Reference | Date | Country | Product | Batches | Action | Class | Source |
|---|---|---|---|---|---|---|---|
| DEA-XXX-2026-0003 | 03 Jul 2026 | XX | DARZALEX (daratumumab) | MYS7381 · STV1K01 | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-EG-2026-0070 | Jul 2026 | EG | Tagrisso 80 mg film-coated tablets | FEST | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-XXX-2026-0002 | 16 Jun 2026 | XX | JAKAVI (ruxolitinib) | none published | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-EG-2026-0062 | Jun 2026 | EG | COLOVERIN-D 30 film Coated Tablets | 251035A | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-EG-2026-0061 | Jun 2026 | EG | FLOPADEX 8mg Hard gelatin capsules 30 | 2504626 | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-EG-2026-0060 | Jun 2026 | EG | Tears Guard Artificial Tears & Lubricant (Sterile Ophthalmic Solution) | 0425118 | Public warning | Unclassified | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2025). DEA-EG-2025-0080: Zithrokan capsule — Mise en garde au public, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2025/dea-eg-2025-0080Version history
v1Manufacturer removed: the notice describes packs of unknown origin; 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.