Egyptian Drug Authority · Egypt
DEA-EG-2026-0075
Tier 1 · Regulator-publishedClass IIRecallStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- report no.(75) For 2026
- Date issued
- Aug 2026
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Product
- karbalta 30 mg Hard Gelatin capsules containing Delayed Release pellets karbalta 60mg Hard Gelatin capsules containing modified Release pellets
- 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
- M1133725 · M1133825
- 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
- karbalta 30 mg Hard
Gelatin capsules
containing Delayed
Release pellets
karbalta 60mg Hard
Gelatin capsules
containing modified
Release pellets
M1133725 M1133825
9/2028
Mash
وذلـــك لكـــون التشغيلات الموضحة بعاليه من
المســـتحضرين قد صدر لهما عدم مطابقة من
معامل هيئة الدواء المصرية
وقف تداول و ضبط وتحريزالتشغيلة من المستحضر
الصادر لها عدم مطابقة
في حالة الشك في المستحضر الصيدلى يتمالرجوع
إلى هيئة الدواء المصرية سواء بالإتصال بالخط
الساخن 15301او الموقع الإلكترونى الخاص بالهيئة.
II
أغسطس2026
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. Karbalta 30 mg hard gelatin capsules containing delayed release pellets and Karbalta 60mg hard gelatin capsules containing modified release pellets, of Mash, batches M1133725 and M1133825, expiry 9/2028, a finding of non-conformity having been issued for the batches 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- Superseded by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
- fbcc80be69b67d406617ec2e3584b774266559dc70ec04180d7d6a90b8a86812SHA-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 20:50:54 UTC
Cite this record
Drug Eye Africa (2026). DEA-EG-2026-0075: karbalta 30 mg Hard Gelatin capsules containing Delayed Release pellets karbalta 60mg Hard Gelatin capsules containing modified Release pellets — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0075Version 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.