Date: October 24, 2025
DRAP Recall Alert No.: II/S/10-25-101
Target Audience:
– National Regulatory Field Force
– Healthcare Professionals (Physicians, Pharmacists, Nurses)
– General Public
Issue Summary:
The Provincial Drug Testing Laboratory has reported that the following product has been declared “Substandard” and “Adulterated.”
Affected Product:
| S# | Product Name | Batch No. | Manufacturer | Remarks |
|---|---|---|---|---|
| 1 | Kanadex-N Cream (Each gram contains: Dexamethasone-21 phosphate disodium salt- 1 mg, Neomycin sulphate 3500 I.U.) – Reg. # 012475 | D7-22 & F7-27 | M/s ISIS Pharmaceutical & Chemical Works, 25/1-3 Sector 12-C, North Karachi Industrial Area, Karachi (DML # 000126) | The product was found Substandard based on low assay of Dexamethasone Phosphate (disodium salt) and Adulterated due to the detection of undeclared Dexamethasone base (0.343 mg/g) by HPLC analysis, which was not mentioned on the label. |
Risk Statement:
The detection of an undeclared corticosteroid alongside sub-therapeutic levels of the declared active ingredient poses serious clinical concerns. Such formulation defects may cause reduced treatment effectiveness, skin thinning (atrophy), hormonal imbalances, and systemic corticosteroid exposure, particularly with prolonged or extensive application.
Patients using this cream for eczema, dermatitis, or other inflammatory skin conditions—especially children and those applying it on large skin areas—are at higher risk.
Use of this defective product compromises both treatment safety and therapeutic efficacy, potentially leading to dermatological or systemic adverse effects.
Actions Taken
The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned unregistered/falsified products.
Pharmacists, chemists, distributors, and healthcare professionals must urgently inspect their stocks. Details of suppliers of such products should be reported to the Regulatory Field Force (DRAP and Provincial Drug Control Departments) to ensure removal from circulation.
Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms@dra.gov.pk.
Guidance for Healthcare Professionals
Any adverse events or quality concerns linked to these medicines should be reported to the National or Provincial Pharmacovigilance Centres via the Adverse Event Reporting Form or through the official online portal.
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Guidance for Consumers
Consumers must avoid these products. If anyone experiences health problems after using them, they should immediately consult a healthcare provider and report the incident to DRAP / the National Pharmacovigilance Centre.
Always purchase therapeutic goods only from licensed pharmacies or authorized outlets. Carefully check the authenticity and condition of products, and consult a pharmacist or healthcare professional in case of doubt.
Reference:
Drug Regulatory Authority of Pakistan. (2025, October 24). Recall Alert – Cream Kanadex-N (Batch # D7-22 & F7-27) – Substandard (Alert No. II/S/10-25-101). https://www.dra.gov.pk/safety_info/product_recalls/recall-alerts/recall-alert-cream-kanadex-n-batch-d7-22-f7-27-substandard/
