Egyptian Drug Authority · Egypt
DEA-EG-2025-0082
Tier 1 · Regulator-publishedClass IIسحبStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- periodic report no(82) For 2025
- Date issued
- Oct 2025
- Recorded by us
- 2026-09-06 19:45:29 UTC
- المستحضر
- Toltra-chem1L oral 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
- 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
- CHV250208
- تواريخ انتهاء الصلاحية
- Not published with the notice
- Action type
- سحب
- التصنيف
- 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
- نص الإخطار
- Toltra-chem1L oral solution
CHV250208
2/2028
ذلك لكون المستحضر صادر له عدم
مطابقة للتشغيلة الموضحة منقبل
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.
أكتوبر2025
اسم المستحضر
رقم التشغيلة
سبب التحذير
الإجراءات
التصحيحية
نصائح
للمستهلكين
منشور
سحب
تاريخالانتهاء
هذا التنبية خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق
على تداول المستحضر بشكل عامOriginal language: ar
- نص الإخطار بالإنجليزية
- Recall, halt of circulation and seizure. Toltra-chem 1L oral solution, batch CHV250208, expiry 2/2028, 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.
- الحالة
- سارٍ
- Superseded by
- Not superseded.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/mpkn0djz/%D9%86%D8%B4%D8%B1-%D8%B3%D8%AD%D8%A8-1638-toltra.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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 75a6b20f6d9cff98a0d1c56ba49243349250d4cf112342a83168fe72e2384033SHA-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 20:47:47 UTC
Cite this record
Drug Eye Africa (2025). DEA-EG-2025-0082: Toltra-chem1L oral solution — سحب, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2025/dea-eg-2025-0082Version 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.