Egyptian Drug Authority · Egypt
DEA-EG-2025-0060
Tier 1 · Regulator-publishedClass IIRecallStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- periodic report no(60) For 2025
- Date issued
- Sept 2025
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Product
- Hycyanaro1.5 % 15mg/1ml sterile ophthalmic solution
- 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
- 240623
- 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
- Hycyanaro 1.5 % 15mg/1ml
sterile ophthalmic solution
240623
Rameda FOR Talent Pharma
Group for Pharmaceuticals
ذلك لكون المستحضر صادر لهعدم
مطابقة للتشغيلة الموضحة من
قبل معامل هيئة الدواء
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.
سبتمبر2025
اسم المستحضر
رقم التشغيلة
سبب التحذير
الإجراءات
التصحيحية
نصائح
للمستهلكين
منشور
سحب
الشركة المصنعة
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. Hycyanaro 1.5% 15mg/1ml sterile ophthalmic solution, batch 240623, made by Rameda for Talent Pharma Group for Pharmaceuticals, because a finding of non-conformity has been issued for the stated batch by the Egyptian Drug Authority laboratories.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- Superseded by
- Not superseded.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.
- Primary source
- https://edaegypt.gov.eg/media/2yymv1br/hycyanaro-%D9%86%D8%B4%D8%B1-%D8%B3%D8%AD%D8%A8.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
- fc9b128215aa6943211e7dc2c66eac5731f38db9d5bc7dd972cccdb13e214ccaSHA-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 20:47:03 UTC
Cite this record
Drug Eye Africa (2025). DEA-EG-2025-0060: Hycyanaro1.5 % 15mg/1ml sterile ophthalmic solution — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2025/dea-eg-2025-0060Version 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.