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

Ahsan Hafiz Recall Alerts

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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.

      Rapid Alert: CONTAMINATED PROPYLENE GLYCOL (BATCH # YFO1210911) PURPOTEDLY MANUFACTURED BY M/S. DONGYING HI-TECH SPRING CHEMICAL INDUSTRY CO LTD, CHINA.

      Muhammad Ayub Naveed Recall Alerts
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      Rapid Alert

      DRAP Alert NoNo  I/S/03-25-32
      Action Date15th March, 2025
      Target Audience1. Regulatory Field Force.
      2. Therapeutic Goods industry
      3. Manufactures of Oral liquid preparations
      4. Healthcare professionals
      Problem StatementDirectorate Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan vide test/analysis report No. 141002343, wherein the sample of Propylene Glycol (Raw Material) has been declared ‘Substandard’. The falsified excipient was detected in the unregulated supply chain marketed through Facebook page and tested by Drug Testing Laboratory (DTL), Lahore. The contaminated propylene glycol batch (YFO1210911) was purported to be manufactured by Dongying Hi-Tech Spring Chemical Industry China. The results of test have revealed that the level of EG in the batch was 91.4%, far exceeding the accepted criteria of 0.1%. Details of test/analysis report are tabulated as under:

      The product identification details are as under: –

      Therapeutic Good Affected:-

      ProductBatch No*Mfg DateExp. DateManufacturer Name
      (as per label)      		Remarks
      Propylene Glycol
      (Raw material)      		YFO121091101-202401-2026M/s. Dongying Hi-Tech Spring Chemical Industry Co Ltd, ChinaThe sample is declared substandard
      due to conatmination of Ethylene Glycol.
      (Note: Earlier in December 2024, DRAP issued a Rapid Alert for the same batch of falsified Propylene Glycol (Raw material) tested by CDL Karachi in compliance to advisory issued by DRAP vide No. 03-41/2023-QC dated 01-12-2023. In this regard, Hi Tech Spring China has confirmed that the said batch is not their product. The firm has provided the original product label, and a comparison between the original and falsified product labels is presented below)

      Risk StatementDi-Ethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
      Action InitiatedThe Regulatory Field Force has directed to take increase surveillance for identification of above mentioned contaminated batch of Propylene Glycol in the market and is investigating the entire supply chain of this batch. The Regulatory Field Force has also been instructed to seize all oral preparations manufactured using the same batch of propylene glycol if found in the market.
      Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
       
      1.      Recall Products: If any batch was manufactured using the same lot of Propylene Glycol that has been identified as contaminated, all finished products from local and export markets should be recalled.
      2.      Hold Other Batches: All finished products manufactured from the same lot of propylene glycol should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain.
      3.      Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.
      4.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.
      5.      Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.

      Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
      Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres.

      -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

      -Please click here for further information on problem reporting to DRAP.
      Advice for ConsumersConsumers should stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

      All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

      Rapid Alert: CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUGS

      Muhammad Ayub Naveed Recall Alerts
      Download

      Rapid Alert

      DRAP Alert NoNo  I/S/03-25-31
      Action Date13th March, 2025
      Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
      2. Healthcare Professionals
      3. Pharmacies and medical stores
      Problem StatementDirectorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared ‘Spurious’. The details of the report are as under:

      The product identification details are as under: –

      Therapeutic Good Affected:-

      ProductBatch No*Mfg DateExp. DateManufacturer Name
      (as per label)      		Remarks
      PENIVET-5 Injection
      Each vial contains:
      Benzyl Penicillin……500,000IU
      Procaine Penicillin….1500,000IU
      Streptomycin Sulphate…5g 
       
      (For Veterinary use only)
       
      Reg. No. 034290      		VK-1496Purported to be manufactured by
      M/s. Star Laboratories (Pvt) Ltd. 
      (Animal Health Care Division) 23-Km, Multan Road, Lahore-Pakistan      		Spurious with regardsto Section 3(zb)(i) & (ii) of Drugs Act 1976 and  ‘Substandard’ on the basis of Sterility test.

      Risk StatementFalsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
      Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified products. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
      Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
      Advice for ConsumersConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

      All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

      Rapid Alert: CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUGS

      Muhammad Ayub Naveed Recall Alerts
      Download

      Rapid Alert

      DRAP Alert NoNo  I/S/03-25-30
      Action Date13th March, 2025
      Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
      2. Healthcare Professionals
      3. Pharmacies and medical stores
      Problem StatementDirectorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’. The detail of report is as under

      The product identification details are as under: –

      Therapeutic Good Affected:-

      ProductBatch No*Mfg DateExp. DateManufacturer Name
      (as per label)      		Remarks
      KLOZEN Eye Drops 5ml
      (Tobramycin….0.3% & Dexamethasone….0.1%)      		138M/s Zinta Pharmaceutical Industry,
      168 – Industrial Estate Hyatabad, Peshawar.      		‘Spurious’ with regards to Section 3(zb)(i) and ‘Adulterated’ with regards to Section 3(a)(iv) of Drugs Act, 1976.

      Risk StatementFalsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
      Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified products. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
      Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
      Advice for ConsumersConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

      All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

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

      Muhammad Ayub Naveed Recall Alerts

      Recall Alert

      Download

      DRAP Alert NoNo I/S/03-25-28
      Action Date12th 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

       
      Syrup Divanza 120ml

       
      Reg. No. 096103

      		Each 5ml contains:
      Sodium Valproate eq. to Valproic acid …..250mg      		021M/s. Hiranis Pharmaceuticals (Pvt.) Ltd.
      E-145-149, North Western Industrial Zone, Port Qasim, Karachi.
      Tablet Mebrosil Antacid

       
      Reg. No. 007733
      		Each tablet contains:
      Magnesium Trisilicate…500mg,
      Aluminium Hydroxide…250mg      		8576M/s. Jawa Pharmaceuticals (Pvt) Ltd,
      112/10 Quaid-e-Azam Industrial Area, Kot-Lakhpat, Lahore.
      Capsule Lanroz 30mg

       
      Reg. No. 047803
      		Each capsule contains:
      Lansoprazole….30mg      		C-032M/s. Hisun Pharmaceuticals Indsutries,
      37-A, R-2, Industrial Estate, Gadoon-Pakistan.
      Sterile Disposable Fresline

       
      Reg. No. MDIR-0001626      		(Tubing Sets for Hemodialysis)2401151264Manufactured by: M/s Vital Healthcare SDN. BHD.,
      Lot 3, Jalan sultan Mohamed 3, Bandar Sultan Sulaiman, 42000 Pelabuhan klang, Selangor Darul Ehsan, Malaysia.
       
      Imported by: Fresenius Medical Care Pakistan (Pvt.) Ltd.,
      TAMC, First Floor, 27-C III, M.M Alam Road, Gulberg III, Lahore.
      Tablet AMLOShine 5mg

       
      Reg. No.  062420      		Each tablet contains:
      Amlodipine as besylate…5mg      		6752M/s Sunshine Pharmaceuticals,
      Khan payara, near Saim Nala, Emanabad Road, Emanabad, Gujranwala
      AME-CLOP Injection

       
      Reg. No. 048388      		Each 2ml contains:
      Metoclopramide HCL….10mg      		MC-120M/s Ameer Pharma (Pvt) Ltd.,
      23-Km, Sheikhupura Road, Lahore.
      Injection Anacobin 500µg

       
      Reg. No. 047494
      		(Mecobalamin 500 µg/ml, 1ml)AF133M/s Epharm Laboratories,
      A-40, Road No. 1, S.I.T.E., Super Highway, Industrial Area, North Karachi.
      Tablet Normax 5mg

       
      Reg. No. 062644      		Each tablet contains:
      Amlodipine as besylate…..5mg      		327M/s Murfy Pharmaceuticals (Pvt) Ltd.,
      8-Km Raiwind Road, Lahore.
      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.

        Rapid Alert: CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUGS

        Muhammad Ayub Naveed Recall Alerts
        Download

        Rapid Alert

        DRAP Alert NoNo  I/S/03-25-28
        Action Date5th March, 2025
        Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
        2. Healthcare Professionals
        3. Pharmacies and medical stores
        Problem StatementDirectorate of Drug Control Punjab (DDCP) has informed the Drug Regulatory Authority of Pakistan that the samples of the below mentioned products have been declared ‘Spurious’.

        The product identification details are as under: –

        Therapeutic Good Affected:-

        ProductBatch No*Mfg DateExp. DateManufacturer Name
        (as per label)        		Remarks
        Syrup Carenol 60mL
        Each 5ml contains:
        Ammonium chloride 125mg,
        Sodium Citrate 55mg, Chlorpheniramine maleate 2.5mg
         
        Reg. No. 026907        		CL-036Purported to be manufactured by
        Well Care Pharmaceuticals, A/7, P.S.I.E. Sargodha-Pakistan.        		‘Spurious’ as per Drugs Act 1976, section 3(z-b) (i) and ‘Misbranded’  as per  section 39(s)(vi).
        Powder for Inj. 2Sum 2g
        Sterile powder of Cefoperazone sodium  eq. to Cefoperazone 1g, Sterile powder for sulbactam sodium eq. to Sulbactum  1g per vial
         
        Reg. No. 071447        		APK072Purported to be manufactured by
        Healthtek (Pvt) Ltd, Plot No. 14, Sector 19, Korangi Industrial Area Karachi -Pakistan.        		Spurious’ as per Drugs Act 1976, section 3(z-b) (i) & (ii) and ‘Adulterated’  as per  section 3(s)(iv) and ‘Substandard’ on the basis of Sterility.

        Risk StatementFalsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
        Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified products. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
        Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
        Advice for ConsumersConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

        All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

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

        Muhammad Ayub Naveed Product Recalls, Recall Alerts

        Recall Alert

        Download

        DRAP Alert NoNo I/S/03-25-26
        Action Date4th 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 Drugs Control (DDC) Punjab and Senior Drug Inspector ICT Islamabad has informed DRAP that samples below product has been reported substandard due to presence of impurities by Drug Testing Laboratory (DTL) Lahore and Rawalpindi:

        Therapeutic Goods (s) Affected: –

        Product NamesCompositionBatch DetailsManufactured by

         
        Ame-Pin injection 2ml

        		Tramadol HCl 100mgTD-038Ameer Pharma (Pvt.) Ltd., 23 KM, Sheikhupura road, Lahore
        Aqua-P Injection
        		Sterile Water For InjectionP-665Ipram International, Plot No. 26, SS-3, NIZ, Rawat Islamabad
        Flagyl Infusion
        		Metronidazole 500mgAD460Sanofi-Aventis Pakistan Ltd., Plot No. 23, Sector 22, KIA, Karachi
        Metroin Infusion
        		Metronidazole 500mgMT24-103Saturn Pharmaceuticals, 23Km,Thokar-Raiwind Rd, Lahore
        Euro-Flow CannulaIV Cannula24/87Euromed for Medical Industries SAE Cairo Egypt
        Rudazole Injection
        		Metronidazole 500mgRD-044Rukha Pharmaceutical & Laboratories, 537-D&E Sundar Industrial Estate Lahore
        Safemed Injection
        		Metronidazole 500mgS-699Ahad Intl., Pharmaceutical, 13KM Gomal Uni, Multan Road, DI Khan
        Pulmowell 120ml syrup
        		(Ammonium Chloride 30mg, Liquorice Ext. 50mg, Aniseed Oil 2.6ml)PLW-001Vital Phyto Parma (Pvt.) Ltd., 7 KM from GT Road, Sohawa Chakwal Road, Rawalpindi
        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:

          Muhammad Ayub Naveed Recall Alerts

          Recall Alert

          Download

          DRAP Alert NoNo I/S/03-25-27
          Action Date4th 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
           Aqua-P InjectionSterile Water For InjectionP-665Ipram International, Plot No. 26, SS-3, NIZ, Rawat Islamabad
          Injection Neocobal 1 ml

          Reg. No. 071447          		Mecobalamin 0.5mg/mlS-2216M/s. Pulse Pharmaceuticals (Pvt.) Ltd.
          Sua Aasil, Raiwind Road, Lahore – Pakistan
          Syrup Antimin 60ml
          Reg. No. 025951          		Each 5ml contains:
          Loratadine …..5mg          		063M/s. Shaigan Pharmaceuticals (Pvt) Ltd,
          14-Km, Adyala Road, Rawalpindi – Pakistan
          Injection Cara-Lac

          Reg. No. 054997          		Ketorolac Tromethamine 30mg/mL24J013M/s. Caraway Pharmaceuticals,
          Plot 12, St. N-3, National Industrial Zone (RCCI), Rawat, Islamabad.
          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.

            Rapid Alert: Presence of Unregistered Tramadol Formulations in the Market

            Muhammad Ayub Naveed Recall Alerts
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            Rapid Alert

            DRAP Alert NoNo  I/S/02-25-25
            Action Date27th February, 2025
            Target Audience1. Regulatory Field Force.
            2. Therapeutic Goods Industry
            3. Manufactures of Oral liquid preparations
            4. Healthcare professionals
            Problem StatementThe Federal Government Analyst, CDL, Karachi has notified the Drug Regulatory Authority of Pakistan that samples of the following products, seized by Customs, have been declared ‘Unregistered’ (falsified). The labels of these samples claim ‘Tramadol hydrochloride’ which has been confirmed by the test reports. Moreover, the labels do not provide any information regarding the manufacturer. The details of the reports are as below:

            The product identification details are as under: –

            Therapeutic Good Affected:-

            ProductBatch No*Mfg DateExp. DateManufacturer Name
            (as per label)            		Remarks
            Tramaking 225 TabletsTM-04403-202303-2026–Un-Registered (Falsified)
            New Tramadol 225 TabletsTRD201502-202202-2027–Un-Registered (Falsified)
            TramaKing 250 CapsuleTKC200103-202203-2027–Un-Registered (Falsified)
            New Royal 225mg TabletsTM-03704-202304-2026–Un-Registered (Falsified)
            Tamral-250 Tablets243NIL03-2026–Un-Registered (Falsified)
            Tramaking Mega 225 TabletsTRD200205-202205-2027–Un-Registered (Falsified)
            TramaKing 250 TabletsTRK200103-202203-2027–Un-Registered (Falsified)

            Risk StatementFalsified products having no identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
            Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified products. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
            Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
            Advice for ConsumersConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

            All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.