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Author: Ahsan Hafiz

Recall Alert: SUBSTANDARD PRODUCTS DECLARED BY PROVINCIAL DRUG TESTING LABORATORIES.

Ahsan Hafiz Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/04-25-35
Action Date07th April, 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 Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

Therapeutic Goods (s) Affected: –

Product NamesCompositionBatch DetailsManufactured byTest Results
Amekoran Injection

 
Reg. No. 053627		Each 2mL contains:
Amikacin (as Sulphate).…250mg		BK-019M/s Ameer Pharma (Pvt) Ltd,
23-Km, Sheikhupura Road, Lahore.		‘Substandard’ on the basis of visible particulates.
Ortizin Tablet

 
Reg. No. 025405		Each film coated tablet contains:
Cetirizine dihydrochloride.…10mg		24I268M/s. Obsons Pharmaceuticals,
209-S, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore.		‘Substandard’ with regards to impurities.
AQUA-P Injection

 
Reg. No. 034290		Sterile water for Injection 5mlP-669M/s. IPRAM International,
Plot No. 26, St # S.S-3, National Industrial Zone,  Rawat.		‘Substandard’ on the basis of visible particulate matter. 
Injection Dorcip 100ml


Reg. No. 046086		Ciprofloxacin as lactate….2mg/mlDC-121M/s. Trigon Pharmaceuticals (Pvt) Ltd. 8-Km, Thokar Raiwind Road, Lahore.  ‘Substandard’ with regards to visible particulates in injection and Sterility Test.
Meclomine Tablet 500mcg

Reg. No.  042601		Each film coated tablet contains:
Mecobalamine…500mcg		8482M/s Alfalah Pharma (PVT) Ltd.,
12-Km, Sheikhupura Road, Lahore.		‘Adulterated’ as per section 3(a)(iv) of Drugs Act, 1976.
Meclomine Tablet 500mcg


Reg. No. 042601		Each film coated tablet contains:
Mecobalamine…500mcg		8440M/s Alfalah Pharma (PVT) Ltd.,
12-Km, Sheikhupura Road, Lahore.		‘Substandard’ on the basis ofPhysical Description & Assay Testand ‘Adulterated’ as per section 3(a)(iv) of Drugs Act, 1976.
Injection Neocobal

Reg. No. 042601		Mecobalamine 0.5mg/mlS-2455M/s Pulse Pharmaceuticals (Pvt.) Ltd.,
Sua Aasil, Raiwind Road, Lahore.		‘Substandard’ on the basis ofAssay Testand ‘Adulterated’ as per Drugs Act, 1976.
Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
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.

    Recall Alert: Substandard Products Declared by Provincial Drug Testing Laboratories.

    Ahsan Hafiz Recall Alerts

    Recall Alert

    Download

    DRAP Alert NoNo I/S/03-25-34
    Action Date27th March, 2025.
    Target Audience– National Regulatory Field Force of DRAP and Provincial Drug Control Departments
    – Healthcare Professionals – Veterinarians
    – Farmers/consumers
    Problem / Issue Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been reported as ‘Substandard’.

    Therapeutic Goods (s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by

     
    Zaktyl-20 Injection

    For veterinary use only
     
    Reg. No. 052317

    		Tylosin Tartrate 230mg/100mlZKA077M/s Zakfas Pharmaceuticals (Pvt) Ltd.
    12-Km, Bosan Road, Multan.
    Risk Statement:The use of substandard veterinary product can result in therapy failure, increasing the risk of complications and potentially contribute to the development of drug resistance
    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 the mentioned batch of the product from the market.
    Advice for VeterinariansDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.

    -Please click here for further information on problem reporting to DRAP.
    Advice for Farmers/ ConsumersFarmers/consumers should not use this product. They shall contact their veterinarians or healthcare provider(s) if the animal experienced any problem that may be related to using this product.

      Recall Alert: Substandard Products Declared by Provincial Drug Testing Laboratories

      Ahsan Hafiz Recall Alerts

      Recall Alert

      Download

      DRAP Alert NoNo I/S/03-25-33
      Action Date27th March, 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 Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by

       
      Tablet AMLOShine 5mg

       
      Reg. No. 062420

      		Each tablet contains:
      Amlodipine as besylate…5mg      		7974M/s Sunshine Pharmaceuticals,
      Khan payara, near Saim Nala, Emanabad Road, Emanabad, Gujranwala
      Powder for Inj. Tyclan

       
      Reg. No. 087923
      		Each vial contains:
      Teicoplanin B.P….400mg      		TL-011M/s. MTI Medical (Pvt) Ltd,
      586-587, Sundar Industrial Estate, Lahore.
      Injection Linco-HCL

       
      Reg. No. 023729
      		Each 2ml ampoule contains:
      Lincomycin as HCl….600mg      		LN-042M/s. Trigon Pharmaceuticals (Pvt) Ltd.
      8-Km, Thokar Raiwind Road, Lahore.
      Safemed Infusion

       
      Reg. No. 045824      		Each 100ml vial contains:
      Metronidazole…500mg      		SJU-1724M/s. Ahad International Pharmaceuticals Ltd.
      13-Km, Gomal University, Multan Road Dera Ismail Khan. 
      Ketamine hydrochloride Injection

       
      Reg. No.  NA      		Each ml contains:
      Ketamine hydrochloride eq. to ketamine …50mg      		GN1359M/s KWALITY Pharmaceuticals Ltd.,
      Nag kalan, Majitha Road, Amristsar 143 601 (India).
      Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
      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.