Egyptian Drug Authority · Egypt
DEA-EG-2026-0069
Tier 1 · Regulator-publishedClass IIRecallStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- report no.(69) For 2026
- Date issued
- Jul 2026
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Product
- Perloc 40 mg Lyophilized powder for reconstitution for I.V infusion/injection
- 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
- 255201
- 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
- Perloc 40 mg Lyophilized powder for
reconstitution for I.V infusion/injection
255201
11/2028
Rameda for European Egyptian
pharmaceutical industries
وذلـــك لكـــون التشغيلة الموضحة بعاليه من
المســـتحضر قد صدر لها عدم مطابقة من معامل
هيئة الدواء المصرية
وقف تداول و ضبط وتحريزالتشغيلة من المستحضر
الصادر لها عدم مطابقة
-في حالة الشك في المستحضر الصيدلى يتم الرجوع
الى هيئة الدواء المصرية سواء بالإتصال بالخط
الساخن 15301او الموقع الإلكترونى الخاص بالهيئة.
II
يوليو2026
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 الانتهاء
ClassOriginal language: ar
- Notice text in English
- Notice. Perloc 40 mg lyophilized powder for reconstitution for intravenous infusion or injection, batch 255201, expiry 11/2028, made by Rameda for European Egyptian Pharmaceutical Industries, a finding of non-conformity having been issued for the batch set out above.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- Superseded by
- Not superseded.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
- faf9954d3d0d3ec4d03c0d420f6346727ad9379aadcbdbd291b68e738d551321SHA-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 20:50:42 UTC
Cite this record
Drug Eye Africa (2026). DEA-EG-2026-0069: Perloc 40 mg Lyophilized powder for reconstitution for I.V infusion/injection — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0069Version 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.