RECORDS ARE PUBLISHED REGULATORY ACTIONS. FIELDS THE ISSUING AUTHORITY DID NOT PUBLISH ARE MARKED AS NOT STATED, NEVER FILLED IN.
Drug Eye AfricaNational Actions, Continental Reach
Register / Egypt / DEA-EG-2022-0004
Egyptian Drug Authority · Egypt
DEA-EG-2022-0004
Tier 1 · Regulator-publishedUnclassifiedRecallStatus · active
Issuing authority
Egyptian Drug Authority (EDA)
Authority reference
Periodic report no.(4) For 2022
Date issued
21 Mar 2022
Recorded by us
2026-09-06 19:45:29 UTC
Product
Gentaderm 1 mg/gm topical cream
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
6061043
Expiry dates
Not published with the notice
Action type
Recall
Classification
Not stated by the issuing authority
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
@egyptiandrugauthority www.edaegypt.gov.eg 15301 ١٢ مارس ٢٢٠٢ وذلك لكون المســـتحضر صادر له عدم مطابقة نهائية من معامل هيئة الدواء المصرية Gentaderm 1 mg/gm topical cream 6061043رقم التشغيلة الشركة المالكة والمصنعة للمستحضر:الفرعونية للأدوية ) فارو فارما ( يتم ضبط وتحريز العبوات من المستحضر التالي: منشور سحب وتحريز غير مطابق Gentaderm
Original language: ar
Notice text in English
Recall and seizure circular, non-conforming. The packs of the following product are to be impounded and seized: Gentaderm 1 mg/gm topical cream, batch number 6061043. The company owning and manufacturing the product is Pharaonia Pharmaceuticals (Pharo Pharma). A final finding of non-conformity has been issued for the product by the laboratories of the Egyptian Drug Authority. Dated 21 March 2022.
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Superseded by
Not superseded.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

Provenance

Verification tier 1

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Fingerprint
f64099cc5a75456f7cd22d2c1c006220f925da8469a4634a5f3978bb5412b015
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Copy taken
2026-09-06 20:35:30 UTC
Cite this record
Drug Eye Africa (2022). DEA-EG-2022-0004: Gentaderm 1 mg/gm topical cream — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2022/dea-eg-2022-0004

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No version history recorded for this record.
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Verification

Tier 1Published 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.

DEA-EG-2022-0004 — Gentaderm 1 mg/gm topical cream · Drug Eye Africa