Egyptian Drug Authority · Egypt
DEA-EG-2026-0001
Tier 1 · Regulator-publishedClass IIRecallStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- Periodic report no.(1) For 2026
- Date issued
- Jan 2026
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Product
- DiclacAmpoule 75 mg
- 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
- Y0011
- 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
- Diclac Ampoule 75 mg
CMO - Novartis Pharma S.A.E, Cairo ,
Egypt for Sandoz
Y0011
4/2027
وذلـــك نظرًا لعدم مطابقة التشغيلةمن
حيث دراسة الثبات طويلة المدى و ذلك
طبقا لما ورد الينا في افادة شركة ساندوز
سحب ووقف تداول وتحريز التشغيلةمن
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.
يناير 2026
اسم المستحضر
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
الشركة المنتجة
تاريخ الانتهاءOriginal language: ar
- Notice text in English
- Recall. Diclac Ampoule 75 mg, batch Y0011, expiry 4/2027, manufactured under contract by Novartis Pharma S.A.E, Cairo, Egypt for Sandoz. The batch does not conform on long-term stability testing, according to a statement received from Sandoz.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- Superseded by
- Not superseded.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
- 3
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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 8c012cefc5afc251d66529456b8ad3b26504f0b245d9203a5e2c0885b4b620c2SHA-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 20:48:26 UTC
Cite this record
Drug Eye Africa (2026). DEA-EG-2026-0001: DiclacAmpoule 75 mg — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0001Version 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.