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
اقرأ هذه الصفحة بـ: English · العربية · Français · Português
Register / Egypt / DEA-EG-2023-0021
Egyptian Drug Authority · Egypt
DEA-EG-2023-0021
Tier 1 · Regulator-publishedUnclassifiedتحذير للجمهورStatus · active
Issuing authority
Egyptian Drug Authority (EDA)
Authority reference
Periodic report no.(21) For2023
Date issued
Sept 2023
Recorded by us
2026-09-06 19:45:29 UTC
المستحضر
Diflustero Sterile Ophthalmic Emulsion 5 Ml
INN / active substance
Not stated by the issuing authority
Dosage form
Not stated by the issuing authority
Strength
Not stated by the issuing authority
الشركة المصنعة
Not stated by the issuing authority
Manufacturer country
Not stated by the issuing authority
MAH or importer
Not stated by the issuing authority
أرقام التشغيلات
1022253
تواريخ انتهاء الصلاحية
Not published with the notice
Action type
تحذير للجمهور
التصنيف
Not stated by the issuing authority
Indicative severity
Not assessed by Drug Eye Africa
Defect category
مغشوش
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
نص الإخطار
@egyptiandrugauthority www.edaegypt.gov.eg 15301 تحذر هيئة الدواء المصرية من العبوات المقلدة من المستحضر التالي حيث يمكن التفرقة ظاهرياً بين العبوات الأصلية والعبوات المقلدة للمستحضر المذكور -وذلك بناءً على ماورد إلينا من الشركة صاحبة المستحضر- كالآتى: منشور غش تجاري DIFLUSTERO STERILE OPHTHALMIC EMULSION 5 ML ORCHIDIA PHARMACEUTICALالشركة المصنعة 1022253تشغيلة رقم وجميع التشغيلات الأخرى التي تتفق مع المواصفات المذكورة بالعبوة المقلدة كما هو وارد بالمنشور. سبتمبر ٣٢٠٢ Exforge HCT 5mg/160mg/12.5mg B59ZX4 , BDPV3 , BDPW8تشغيلة رقم Novartis Pharma S.A.Eالشركة المصنعة :شركة egyptiandrugauthority www.edaegypt.gov.eg 15301 في حال وجود شكوى يرجى الرجوع للصيدلي للتأكد من العبوة او الاتصال على الخط الساخن ١٠٣٥١ او www.edaegypt.gov.egالابلاغ عبر الموقع الإلكتروني للهيئة DIFLUSTERO STERILE OPHTHALMIC EMULSION 5 ML ORCHIDIA PHARMACEUTICALالشركة المصنعة 1022253تشغيلة رقم Exforge HCT 5mg/160mg/12.5mg B59ZX4 , BDPV3 , BDPW8تشغيلة رقم Novartis Pharma S.A.Eالشركة المصنعة :شركة egyptiandrugauthority www.edaegypt.gov.eg 15301 في حال وجود شكوى يرجى الرجوع للصيدلي للتأكد من العبوة او الاتصال على الخط الساخن ١٠٣٥١ او www.edaegypt.gov.egالابلاغ عبر الموقع الإلكتروني للهيئة DIFLUSTERO STERILE OPHTHALMIC EMULSION 5 ML ORCHIDIA PHARMACEUTICALالشركة المصنعة 1022253تشغيلة رقم
Original language: ar
نص الإخطار بالإنجليزية
Trade-counterfeiting circular. The Egyptian Drug Authority warns against counterfeit packs of the following product: DIFLUSTERO STERILE OPHTHALMIC EMULSION 5 ML, manufactured by Orchidia Pharmaceutical, with the batch number as stated. Genuine and counterfeit packs can be told apart by sight, on the basis of what the company that owns the product has reported to the Authority.
Machine translation, produced by Drug Eye Africa and not checked by the issuing authority. The authority stated only the text above it.
الحالة
سارٍ
Superseded by
Not superseded. This is the current version.
Version
1

Provenance

Verification tier 1

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

Primary source
https://www.edaegypt.gov.eg/media/bsaprl3k/%D9%85%D9%86%D8%B4%D9%88%D8%B1-%D8%AF%D9%88%D8%B1%D9%8A-%D8%B1%D9%82%D9%85-21-%D9%84%D8%B3%D9%86%D8%A9-2023.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
6ba7d4083ab0e729af53b0644dbe1ecfbcfd5c1e6ad33b1e79dd780cca575653
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 20:37:40 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 (2023). DEA-EG-2023-0021: Diflustero Sterile Ophthalmic Emulsion 5 Ml — تحذير للجمهور, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2023/dea-eg-2023-0021

Version history

v1Manufacturer removed: 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-2023-0021