RECORDS ARE PUBLISHED REGULATORY ACTIONS. FIELDS THE ISSUING AUTHORITY DID NOT PUBLISH ARE MARKED AS NOT STATED, NEVER FILLED IN.
Drug Eye AfricaNational Actions, Continental Reach
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Register / Egypt / DEA-EG-2026-0026
Egyptian Drug Authority · Egypt
DEA-EG-2026-0026
Tier 1 · Regulator-publishedUnclassifiedMise en garde au publicStatus · active
Issuing authority
Egyptian Drug Authority (EDA)
Authority reference
Periodic report no.(26) For 2026
Date issued
Apr 2026
Recorded by us
2026-09-06 19:45:29 UTC
Produit
FLOPADEX 8mg Hard Gelatin Capsules
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
2411226
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
FLOPADEX 8mg Hard Gelatin Capsules 2411226رقمالتشغيلة EVA PHARMA وذلك بناءً على ما ورد الينا من منشركة EVA PHARMA صاحبة المستحضر حيث افادت ان العبوات بالاختلافات الموضحة لا تخصها و لميتم تصنيعها بمعرفتها. وقف تداول و ضبط وتحريز المستحضر الغير مطابق للمواصفات في حالة الشك في المستحضر الصيدلىيتم الرجوع الى هيئة الدواء المصرية سواء بالإتصالبالخط الساخن 15301او الموقعالإلكترونىالخاص بالهيئة. يمكن الضغط على الرابطللإطلاععلى الصور الخاصة بالمستحضر الغير مطابق للمواصفات . أبريل 2026 منشور غش تجاري اسم المستحضر الشركة المنتجة سبب التحذير الإجراءات التصحيحية نصائح للمستهلكين هذا التنبيه خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق على تداول المستحضر بشكل عام
Original language: ar
Texte de l’avis en anglais
Notice. FLOPADEX 8mg hard gelatin capsules, batch number 2411226, of EVA Pharma. On the basis of what EVA Pharma, which owns the product, has reported to the Authority, the packs showing the differences described are not theirs and were not manufactured by them.
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
11

Provenance

Verification tier 1

Where this record came from, and what is held to show it.

Primary source
https://www.edaegypt.gov.eg/media/j1bkhb44/flopadex-8mg-hard-gelatin-capsules-1.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
a6c28ca3269a38e1e391ea971d9e8f3e86e361fa462cec6c82cac208a48ae26d
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 20:49:16 UTC

Related actions elsewhere

Same stated defect
ReferenceDateCountryProductBatchesActionClassSource
DEA-XXX-2026-000303 Jul 2026XXDARZALEX (daratumumab)MYS7381 · STV1K01Public warningUnclassifiedTier 1 · Regulator-published
DEA-EG-2026-0070Jul 2026EGTagrisso 80 mg film-coated tabletsFESTPublic warningUnclassifiedTier 1 · Regulator-published
DEA-XXX-2026-000216 Jun 2026XXJAKAVI (ruxolitinib)none publishedPublic warningUnclassifiedTier 1 · Regulator-published
DEA-EG-2026-0062Jun 2026EGCOLOVERIN-D 30 film Coated Tablets251035APublic warningUnclassifiedTier 1 · Regulator-published
DEA-EG-2026-0061Jun 2026EGFLOPADEX 8mg Hard gelatin capsules 302504626Public warningUnclassifiedTier 1 · Regulator-published
DEA-EG-2026-0060Jun 2026EGTears Guard Artificial Tears & Lubricant (Sterile Ophthalmic Solution)0425118Public warningUnclassifiedTier 1 · Regulator-published
Cite this record
Drug Eye Africa (2026). DEA-EG-2026-0026: FLOPADEX 8mg Hard Gelatin Capsules — Mise en garde au public, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0026

Version history

v5Manufacturer removed: the named company states the packs are not theirs; 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-2026-0026