Egyptian Drug Authority · Egypt
DEA-EG-2026-0052
Tier 1 · Regulator-publishedClass IIRappelStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- Periodic report no.(52) For 2026
- Date issued
- Jun 2026
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Produit
- Dexatrolophthalmic & otic suspension
- 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
- EIPICO
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Numéros de lot
- 2501758
- Dates de péremption
- Not published with the notice
- Action type
- Rappel
- 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
- Texte de l’avis
- Dexatrol ophthalmic & otic
suspension
2501758
3/2027
EIPICO
صدور عدم مطابقة لهذه التشغيلة من معامل
هيئة الدواء المصرية
وقف تداول و ضبط وتحريزالتشغيلة من
المستحضر الصادر لها عدم مطابقة
في حالة الشك في المستحضر الصيدلى يتم
الرجوع إلى هيئة الدواء المصرية سواء
بالإتصال بالخط الساخن 15301او الموقع
الإلكترونى الخاص بالهيئة.
يونيو2026
اسم المستحضر
الشركة المصنعة
سبب التحذير
الإجراءات
التصحيحية
نصائح
للمستهلكين
منشور
سحب
هذا التنبية خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق على
تداول المستحضر بشكل عام
رقم التشغيلة
تاريخ الانتهاءOriginal language: ar
- Texte de l’avis en anglais
- Halt of circulation and seizure. Dexatrol ophthalmic and otic suspension, of EIPICO, batch 2501758, expiry 3/2027. A finding of non-conformity has been issued for this batch by the Egyptian Drug Authority laboratories, and the batch for which the finding was issued is to be withdrawn from circulation and seized.Machine translation, produced by Drug Eye Africa and not checked by the issuing authority.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- Superseded by
- Not superseded.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
- 11
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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- f53eb4662e123f123296e249a9016a4c815135d3fd62a6e5630623842a2342b6SHA-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 20:50:08 UTC
Cite this record
Drug Eye Africa (2026). DEA-EG-2026-0052: Dexatrolophthalmic & otic suspension — Rappel, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0052Version 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.