Egyptian Drug Authority · Egypt
DEA-EG-2025-0069
Tier 1 · Regulator-publishedClass IIRecallStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- periodic report no(69) For 2025
- Date issued
- Sept 2025
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Product
- Varde 20mg FCT
- 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
- Not published with the notice
- Expiry dates
- Not published with the notice
- Action type
- Recall
- Classification
- Class II as issued
- 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
- Varde 20mg FCT
105
شركة الحكمة
وذلـــك نظرًا لعدم مطابقة المستحضر
بالبيانات الموضحهبعاليهللمواصفات و
ذلك طبقا لما ورد الينا في افادة شركة
الحكمة
سحب ووقف تداول وتحريز
في حالة الشك في المستحضر الصيدلى يتم
الرجوع إلى هيئة الدواء المصرية سواء
بالإتصال بالخط الساخن 15301او الموقع
الإلكترونى الخاص بالهيئة.
سبتمبر 2025
اسم المستحضر
رقم التشغيلة
سبب التحذير
الإجراءات
التصحيحية
نصائح
للمستهلكين
منشور
سحب
الشركة المنتجة
هذا التنبية خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق
على تداول المستحضر بشكل عامOriginal language: ar
- Notice text in English
- Recall, halt of circulation and seizure. Varde 20mg film coated tablets, of Hikma, batch 105, the product with the particulars set out above not conforming to specification according to a statement received from Hikma.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- Superseded by
- Not superseded.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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 3fc0564985677c06ad9986161cf84ed1af916f9cc23cd4192c6998d67292419cSHA-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 20:47:21 UTC
Cite this record
Drug Eye Africa (2025). DEA-EG-2025-0069: Varde 20mg FCT — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2025/dea-eg-2025-0069Version 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.