Egyptian Drug Authority · Egypt
DEA-EG-2025-0087
Tier 1 · Regulator-publishedClass IRecallStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- periodic report no(87) For 2025
- Date issued
- Nov 2025
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Product
- Haemodialysis concentrate solution (biocarbonate)(1:35) (formula 1048)
- 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
- Not published with the notice
- Expiry dates
- Not published with the notice
- Action type
- Recall
- Classification
- Class I 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
- Haemodialysis concentrate solution
(biocarbonate)(1:35) (formula 1048)
النصر
326/48/2025
36/48/2026
37/48/2026
44/48/2026
45/48/2026
6/2027
صدور عدم مطابقة لهذه التشغيلة من معامل
هيئة الدواء المصرية
سحب ووقف تداول وتحريز التشغيلة من
المستحضر الصادر لها عدم مطابقة
في حالة الشك في المستحضر الصيدلىيتم
الرجوع إلى هيئة الدواء المصرية سواء بالإتصال
بالخط الساخن 15301او الموقع الإلكترونى
الخاص بالهيئة.
نوفمبر 2025
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 المصنعة
تاريخالانتهاءOriginal language: ar
- Notice text in English
- Recall, halt of circulation and seizure. Haemodialysis concentrate solution (bicarbonate) (1:35), formula 1048, of El-Nasr, batches 326/48/2025, 36/48/2026, 37/48/2026, 44/48/2026 and 45/48/2026, expiry 6/2027. A finding of non-conformity has been issued for these batches 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- Superseded by
- Not superseded.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/2kwfnfqt/1645-%D8%B3%D8%AD%D8%A8-haemodialysis-conc-soln.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
- 3858ace78efa95069fa47c35c3d18baaf200db30e21db363a5aa8bffca0772e7SHA-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 20:47:57 UTC
Cite this record
Drug Eye Africa (2025). DEA-EG-2025-0087: Haemodialysis concentrate solution (biocarbonate)(1:35) (formula 1048) — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2025/dea-eg-2025-0087Version 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.