Home > 2025

Year: 2025

RECALL ALERT – BATCHES OF ‘TABLET FAMILA 28F’ DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

Ahsan Hafiz Recall Alerts

Recall Alert

Download

DRAP Alert NoNo II/S/08-25-52
Action Date04 August, 2025.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Central Drugs Laboratory Karachi informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

Product Details: Famila 28F Tablets (Reg. # 023941)

Manufactured by: M/s Zafa Pharmaceuticals Lab (Pvt) Ltd.  (DML # 000490)

Batch No.CDL Test Result / Remarks
K217‘Substandard’ on the basis of tests (Content uniformity of Levonorgestrel & Ethinyl Estradiol. Weight variation of Ferrous Iron).
K177‘Substandard’ on the basis of tests (Content uniformity of Levonorgestrel & Ethinyl Estradiol. Weight variation of Ferrous Iron. Assay test of Levonorgestrel.)
K203, K207‘Substandard’ on the basis of test of weight variation of Ferrous Iron.
K184, K190, K191‘Substandard’ on the basis of tests of Content uniformity of Levonorgestrel & Ethinyl Estradiol. Assay test of Levonorgestrel.
K182‘Substandard’ on the basis of tests of Content uniformity of Levonorgestrel & Ethinyl Estradiol. Weight variation of Ferrous Iron.
K199, K205‘Substandard’ on the basis of tests Content uniformity of Ethinyl Estradiol & Weight variation of Ferrous Iron.
K204‘Substandard’ on the basis of test of Content uniformity of Levonorgestrel & Ethinyl Estradiol.
Risk Statement:The affected batches of Famila 28F Tablets due to content uniformity, assay failures of hormonal ingredients, and weight variation in the iron component, may lead to reduced contraceptive efficacy, hormonal imbalance, and inconsistent iron supplementation.
Use of such products can cause therapy failure and complications.
Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market.

– All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company.

–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.

–Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

    Recall Alert – MEDICAL DEVICES DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

    Ahsan Hafiz Recall Alerts

    Recall Alert

    Download

    DRAP Alert NoNo I/S/07-25-51
    Action Date29 July, 2025.
    Target Audience– National Regulatory Field Force.
    – Pharmacists and Chemists     in Distribution, Pharmacies and Medical Stores
    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
    – General Public
    Problem / Issue Central Drugs Laboratory Karachi informed Drug Regulatory Authority of Pakistan that the samples of below mentioned Medical Devices have been reported as ‘Substandard’.

    Therapeutic Goods (s) Affected: –

    Product NamesBatch DetailsManufactured byTest Results
    ZINDAGI Auto Disable Syringe 5ml
    (MDMR-000117)    		5-01E-25M/s Al-Badar Manufacturing (Pvt.) Ltd. Gadoon Amazai KPK (ELM-0029)‘Substandard’ on the basis of Sterility Test.
    Ultra Fine SMD Painless Syringe 5ml
    (MDMR-000229)    		5053CEM/s Sehat Medical Device (Pvt.) Ltd, Lahore. (ELM-0065) ‘Substandard’ on the basis of Sterility Test & description test (The clear visible black particles found in the barrel of syringe).
    Ultra Fine SMD Painless Syringe 3ml
    (MDMR-000229)    		3022CDM/s Sehat Medical Device (Pvt.) Ltd, Lahore. (ELM-0065) ‘Substandard’ on the basis of Sterility Test & description test (The clear visible black particles found in the barrel of syringe).
    Risk Statement:Use of substandard syringes, in invasive or intravenous procedures, poses a significant risk of introducing microbial contaminants into the patient’s body, which may result in localized infections, abscesses, or life-threatening systemic infections, particularly in immunocompromised individuals.
    Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market.
    – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

    –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.

    –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
    Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

    -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the     Adverse Event Reporting Form or online through this link.

    -Please click here for further information on problem reporting to DRAP.
    Advice for Consumers-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

    -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

      Minutes of the 348th Meeting of the Registration Board Held on 1st-2nd July, 2025

      Muhammad Ayub Naveed Registration Board

      The Drug Registration Board convened its 348th meeting on 1st-2nd July, 2025 in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.

      Minutes-of-348th-Meeting-of-Registration-BoardDownload