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Month: February 2025

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.

Minutes of the 344th Meeting of the Registration Board Held on 31st December, 2024 to 02nd January, 2025

Muhammad Ayub Naveed Registration Board

The Drug Registration Board convened its 344th meeting on December 31st, 2024 to February, 20252 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-344th-Meeting-of-Registration-BoardDownload

Recall Alert: Recall of Substandard Floonix Injection (Batch # Inj-175) Manufactured by M/s Kayans Pharmaceuticals, Islamabad

Muhammad Ayub Naveed Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/02-25-24
Action Date25th February 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 Federal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No. IP-12-24-000101 dated 13-02-2025, has declared the sample of Floonix Injection (Batch # INJ-175), manufactured by M/s Kayans Pharmaceuticals, Islamabad, as ‘Substandard’. Details of test/analysis report are given as under:.

Therapeutic Goods (s) Affected: –

Product NamesCompositionBatch DetailsManufactured by

 
Floonix Injection

 
For Veterinary use only.
 
Reg. No. 112247
Flunixin 50mg/mlNo: INJ-175
Mfg date:     11-2024
Expiry date:
11-2026		M/s. Kayans Pharmaceuticals.
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: CONTAMINATED PROPYLENE GLYCOL (BATCH # A803S96G46) PURPOTEDLY MANUFACTURED BY M/S. DOW CHEMICAL PACIFIC (SINGAPORE) PRIVATE LIMITED.

    Muhammad Ayub Naveed Recall Alerts
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    Rapid Alert

    DRAP Alert NoNo  I/S/02-25-23
    Action Date25th February, 2025
    Target Audience1. Regulatory Field Force.
    2. Therapeutic Goods industry
    3. Manufactures of Oral liquid preparations
    4. Healthcare professionals
    Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No. RM-1-25-000007 dated 20-02-2025, has declared the sample of Propylene glycol (Raw material) as ‘Substandard’ sent to CDL Karachi by the licensed pharmaceutical manufacturer in compliance to advisory issued by DRAP vide No. 03-41/2023-QC dated 01-12-2023. Details of test/analysis report are given 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)    		A803S96G4622-May-202321-May-2025M/s. Dow Chemical Pacific (Singapore) Private LimitedThe sample is declared substandard
    due to conatmination of Ethylene Glycol.

    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.

    Recall Alert: Voluntary Recall of all Batches of Lacolep Injection 10mg/ml Manufactured by M/s Hilton Pharma, Karachi.

    Muhammad Ayub Naveed Recall Alerts

    Recall Alert

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    DRAP Alert NoNo I/S/02-25-22
    Action Date25th February 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 The firm M/s Hilton Pharma (Pvt) Ltd, Karachi, has informed Drug Regulatory Authority of Pakistan regarding voluntary recall of all marketed batches of Lacolep Injection 10mg/ml (Reg # 076086), due to the concerns regarding deviations in the quality parameters of certain batches of the aforementioned drug. In connection with this, the firm has published a public notice in the leading newspaper, The News-Jang, advising all distributors and dealers to return their stocks in hand to their nearest distributors and/or directly to the company.

    Therapeutic Goods (s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by

     
    Lacolep Injection 10mg/mL
     
    Reg. No. 076086
    		Lacosamide
    All marketed batches    		M/s. Hilton Pharma Pvt. Ltd.
    Plot 13 & 14, Sector 15, Korangi Industrial Area, Karachi. 
    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

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      DRAP Alert NoNo I/S/02-25-21
      Action Date20th February 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
      Infusion Safemed 100mL

       
      Reg. No. 045824
       

      		(Metronidazole 500mg /100ml)
      Batch No.
      S-790-A      		M/s. Ahad International Pharmaceuticals Ltd.
      13-Km, Gomal University, Multan Road, Dera Ismail Khan
      Syrup Resfyl 60mL
       

       
      Reg. No. 057214
      		Each 5 mL contains: Acefylline Piperazine 45mg
      Diphenhydramine HCl 8mg      		Batch No.
      4A009      		M/s. Rasco Pharma,
      5.5-Km, Raiwind Road, Lahore.
      Sterile Water for Injection
       
      Reg. No. 024854      		Sterile Water for Injection224M/s. Pharmedic Labs (Pvt) Ltd,
      16-Km Multan Road, Lahore.
      Injection Ame-Pin

       
      Reg. No. 065943      		Tramdol HCl 100mg/2mLTD-038M/s. Ameer Pharma (Pvt) Ltd,
      23-Km, Sheikhupura 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
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        Rapid Alert

        DRAP Alert NoNo  I/S/02-25-20
        Action Date20th February, 2025
        Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
        2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
        3. General Public
        Problem StatementDrug Testing Laboratory, Sindh has notified the Drug Regulatory Authority of Pakistan that samples of following products, collected by various provincial drug inspectors, have been declared ‘Spurious’ (falsified). The details of the reports are as below:

        The product identification details are as under:

        Therapeutic goods affected:

        ProductBatch No*Mfg DateExp. DateManufacturer Name
        (as per label)        		Remarks
        Nuberol Forte Tablets (Paracetamol & Orphenadrine citrate)DB0982Purported to be manufactured by M/s Searle Company Limited, 32-Km Multan Road, LahoreSpurious, Orphenadrine Citrate not identified.
        Phenobar Tablet
        (Phenobaritone)        		QA 008Purported to be manufactured byM/s Star Laboratories (Pvt) Ltd, 23-Km Multan Road, LahoreSpurious, Phenobarbitone not identified.
        Iodex CMS Ointment (Methyl Salicylate)HIAACPurported to be manufactured by M/s GSK Pakistan Limited, F/168, SITE, Karachi.Spurious, Methyl Salicylate not identified.

        Risk Statement:Falsified 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 throughout the supply chain to confiscate the counterfeit product. 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 supplier of such product should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of this product from the circulation.
        Advice for Healthcare ProfessionalsAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products.

        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 at this link.
        Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.

        Recall Alert: Voluntary Recall of 36 Batches of Motival Tablets (Reg # 004539) Manufactured by M/s GSK Pakistan Limited, Karachi.

        Muhammad Ayub Naveed Recall Alerts

        Recall Alert

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        DRAP Alert NoNo I/S/02-25-18
        Action Date18th February 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 The firm M/s GSK Pakistan Limited, Karachi has notified Drug Regulatory Authority of Pakistan that they have initiated voluntary recall of 36 batches of Motival Tablets due to the detection of nitrosamine impurity, N-nitroso nortriptyline. Moreover, the firm has reported that it has ceased the manufacture and release of Motival Tablets. The details of the recalled product lots are as follows:

        Therapeutic Goods (s) Affected: –

        Product NamesCompositionBatch DetailsManufactured by
        Motival Tablets
        5 × 20’s
         
        (Reg # 004539)
         

        		Nortiptyline as HCl 10mg + Fluphenazine HCl 0.5mg
        Batch No.
        9P8L, A95S, A95Y, AN5N, AN5P, AN5R, AN5T, CK7G, CK7H, DT7B, DT7D, DL8J, DT7C, H58X, H58Y, H59A, J77W, J77V, K36F, K36E, KD6N, KD6P, M32F, ME8N, ME8R, R47H, R47K, R47L, SA7F, SA7G, SA6V, WM8R, WM8T, WM8U, YB7A, YB7B.        		M/s. GSK Pakistan Limited, Plot # 5, Sector 21, Korangi Industrial Area, Karachi.
        Risk Statement:The risk of nitrosamine impurity in nortriptyline, like other pharmaceutical products, is a broader concern that has become more prominent after several incidents. These impurities are believed to have carcinogenic potential in certain situations.
        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 Uncategorized
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          Rapid Alert

          DRAP Alert NoNo  I/S/02-25-18
          Action Date17th February, 2025
          Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
          2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
          3. General Public
          Problem StatementDrug Testing Laboratory, Sindh has informed to Drug Regulatory Authority of Pakistan that samples of following products taken by various provincial drug inspectors, have been declared ‘Spurious’ (falsified). Moreover, the following firms and their associated products were found to be fictitious. The details of the reports are as below:

          The product identification details are as under:

          Therapeutic goods affected:

          ProductBatch No*Mfg DateExp. DateManufacturer Name
          (as per label)          		Remarks
          Evosef 250mg capsule
          (Cephradine 250mg)          		HF-001Purported to be manufactured by East Pharmaceutical 19-Km Sheikhupura road, LahoreSpurious. Cephradine not identified
          Mirzpan Suspension 100mg/5ml
          (Cefixime)          		0008M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur.Spurious, Cefixime not identified
          Mirzolam Tablet 0.5mg (Alprazolam)0007M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur.Spurious, Alprazolam not identified
          Bromalax Tablet 3mg (Bromazepam)B-01M/s Brom Pharmaceuticals (Pharmaceutical Industries), 21-Km Ferozpur Road, Lahore.Spurious, Bromazepam not identified
          Malixime Suspension 200mg/5ml
          (Cefixime)          		78011M/s Menakline Pharma, S Site Plot 11, Korangi Industrial Area, Karachi.Spurious, Cefixime not identified
          Lexopam Tablet 3mg (Bromazepam)B-01M/s Porm Pharmaceuticals (Pharmaceutical Industries), 220 Industrial Estate Hayatabad, Peshawar.Spurious, Bromazepam not identified
          Zionex Tablet 0.5mg (Alprazolam)0032M/s Multicare Pharmaceutical, Plot # 23, Korangi Industrial Area, Karachi.Spurious, Alprazolam not identified
          Tramaking-225 Mega tablet 225mg
          (Tramadol HCl)          		TRD2002Name of Manufacturer not mentioned.Spurious
          Alcoxime Suspension 100mg/5ml
          (Cefixime)          		A2011M/s Alpine Laboratories (Pvt.) Ltd: Plot# A-41, S.I.T.E Indsutrial Area, Sector 3 North Karachi Super Highway 75500-Pakistan.Spurious, Cefixime not identified

          Risk Statement:Falsified 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 throughout the supply chain to confiscate the counterfeit product. 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 supplier of such product should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of this product from the circulation.
          Advice for Healthcare ProfessionalsAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products.

          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 at this link.
          Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.