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Author: Muhammad Ayub Naveed

Recall Alert: Substandard Dexyken 300 mg Tablet Batch No. Kf23006  Manufactured By M/s. Kanel Pharma, Plot 6, Street SS-3, Rawat Industrial Estate, IslamabadRecall Alert:

Muhammad Ayub Naveed Recall Alerts, Uncategorized

Recall Alert

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DRAP Alert NoNo I/S/12-24-55
Action Date12th December, 2024.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
– General Public
Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. KQ-9-24-000142 has declared the subject mentioned batch of product Dexyken 300mg tablet as of substandard quality. Details of CDL test report are as under:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Dexyken Tablet

Reg# 075234		Dexibuprofen 300 mgBatch no. KF23006
Mfg date: 06/2023
Expiry date:
06/2025		M/s. Kanel Pharma, Islamabad
Risk Statement:Dexibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce inflammation and pain in conditions such as arthritis. The identified quality issue with these tablets may result in Reduced Efficacy, depending on the degree of substandard quality and the patient’s condition. Vulnerable populations, including elderly patients and those with existing gastrointestinal, cardiovascular, or renal conditions, may be at a higher risk.
Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have 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 Nocox Tablets Batch No. 8463 Manufactured by M/s. Alfalah Pharma (Pvt.) Ltd., 12-Km Lahore Road, Jamal Park, Sheikhupura

    Muhammad Ayub Naveed Recall Alerts

    Recall Alert

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    DRAP Alert NoNo I/S/12-24-54
    Action Date12th December, 2024.
    Target Audience– National Regulatory Field Force.
    – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
    – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
    – General Public
    Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. LHR-10-24-000007 has declared the subject mentioned batch of product Nocox tablet as of substandard quality. Details of CDL test report are as under

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by
    Nocox Tablet

    (Reg# 052499)    		Meloxicam 15mgBatch no. 8463
    Mfg date: 02/2024
    Expiry date:
    02/2026    		M/s. Alfalah Pharma (Pvt.) Ltd., 12-km Lahore Rd, Jamal Park, Sheikhupura
    Risk Statement:Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce inflammation and pain in conditions such as arthritis. The identified quality issue with these tablets may result in Reduced Efficacy, depending on the degree of substandard quality and the patient’s condition. Vulnerable populations, including elderly patients and those with existing gastrointestinal, cardiovascular, or renal conditions, may be at a higher risk.
    Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have 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 # YF01210911) Allegedly 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/12-24-52
      Action Date12th December, 2024
      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-10-24-000624 dated 19-11-2024 declared the sample of Propylene Glycol (Raw material) sent to CDL Karachi by a licensed pharmaceutical manufacturer in compliance to advisory issued by DRAP vide No. 03-41/2023-QC dated 01-12-2023. The supply chain of this raw material is still under investigation. 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)      		YF0121091122-May-202321-May-2025M/s. Dongying Hi-Tech Spring Chemical Industry Co. Ltd., China.[The material found in the packaging with the label of this manufacturer, however product authenticity and supply chain integrity are under investigation and yet not confirmed.]The 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.

      Rapid Alert: Falsified Dayquil Kids (Vicks) Berry Cold & Cough + Mucus Purportedly Manufactured By M/S. Procter & Gamble, Cincinnati, OH 45202.

      Muhammad Ayub Naveed Recall Alerts
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      Rapid Alert

      DRAP Alert NoNo I/S/12-24-51
      Action Date03rd December, 2024
      Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
      ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
      ·        General Public
      Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No. KQ-7-24-000112 dated 15-10-2024 declared the sample of DayQuil Kids (Vicks) as unregistered (Falsified) Drug. The product contains Dextromethorphan HBr which is an allopathic drug, therefore, the said product must be registered with DRAP. The details of the product are as under:

      S#Product NameCompositionBatch No.Manufactured by
      (as per label claim)      		Lab Test Results
      1DayQuil Kids (Vicks) Berry Cold & Cough + MucusNil31254334L4Purported to be manufactured by M/S.PROCTER & GAMBLE, CINCINNATI, OH 45202Spurious
      Risk Statement:DayQuil Kids (Vicks) is a widely available over-the-counter (OTC) medication for cough and flu relief. However, its active ingredient, Dextromethorphan HBr, may pose potential health risks, necessitating regulatory oversight to ensure safe consumption.
      Action InitiatedThe Regulatory Field Force has been directed to take necessary action on the above-mentioned falsified product and is investigating the entire supply chain of this product. The Regulatory Field Force has also been instructed to seize identified falsified products if found on the market.
      Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available at this link.

      Any adverse events or quality problems experienced with the use of these products should be reported to the 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 ConsumerConsumers 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 these 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: Recall Notices for 7 products Issued By Provincial Drug Testing Laboratories

      Muhammad Ayub Naveed Recall Alerts

      Recall Alert

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      DRAP Alert NoNo I/S/11-24-50
      Action Date29th November, 2024.
      Target Audience– National Regulatory Field Force.
      – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
      – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
      – General Public
      Problem / Issue TDDCP PV Lahore and Secretary PQCB Quetta has informed DRAP regarding recall of following batches of mentioned products:

      Therapeutic Good(s) Affected: –

      Sr.No.Product NamesCompositionManufactured byTest Results
      1.Infusion Zeesol-5 1000 mL

      Reg# 016611      		Dextrose Anhydrous 50 g/ 1000mLShazeb Pharmaceutical Industries Limited Hazara Trunk Road, Sarai Gadaee, District Haripur, K.P.K PakistanSubstandard on the basis of Bacterial Endotoxin
      2.Sterile Water for Injection 5 mL

      Reg# 062671      		Sterile Water for InjectionFynk Pharmaceuticals 19-KM. G.T. Road, Kalashah Kaku, LahoreSubstandard” on the basis of Visible Particulates in Injections
      3.Infusion Cyanoco (Vitamin B12) 100mL

      Reg# 041241      		Cyanocobalamin 500 mcg/2mLInternational Pharma Labs Raiwind Road Bhobatian Chowk, Defence Road, 1-KM, towards Kahna LahoreAdulterated
      4.Infusion Cyanoco Super 100mL

      Reg# 041242      		Cyanocobalamin 1000 mcg/2mLInternational Pharma Labs Raiwind Road Bhobatian Chowk, Defence Road, 1-KM, towards Kahna LahoreAdulterated
      5.Syrup Desora

      Reg# 055192      		Desloratadine 0.5mg/mLS.J. & G. Fazul Ellahie (PVT) Ltd., E-46, S.I.T.E., KarachiEthylene Glycol above the permissible limit
      6.Inj. Isanex

      Reg# 024657      		Sterile Powder of Ceftriaxone Sodium
      eq. to Ceftriaxone 1g/Vial      		Humayun International Pharma (PVT) LTD 20-km, Satiana Road, Faisalabad“Substandard” with regards to Sterility Test
      7.EmpLiMet XR tablet

      Reg# 121679      		Empaglifozin, Linagliptin, Metformic HClHorizon Healthcare (Pvt.) Ltd., Plot no. 33, sundar Industrial estate, LahoreSubstandard on the basis of Assay

      Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have 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: Recall of 6 Batches of Neutrozole Infusion Manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore

        Muhammad Ayub Naveed Recall Alerts, Uncategorized

        Recall Alert

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        DRAP Alert NoNo I/S/11-24-51
        Action Date29th November, 2024.
        Target Audience– National Regulatory Field Force.
        – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
        – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
        – General Public
        Problem / Issue The Provincial Inspector of Drugs, Punjab collected the samples of Neutrozole Infusion from various districts of Punjab and sent for test / analysis. The Drugs Testing Laboratory, Multan has declared various batches the said product, manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore, as a Substandard product. The details of the case are as under:

        Therapeutic Good(s) Affected: –

        Product NamesCompositionBatch DetailsManufactured by
        Neutrozole Infusion 100ml
         
        Reg. No. 046878          		Metronidazole (500mg/100ml)Batch No. MZ023,
        MZ028,
        MZ010,
        MZ007,
        MZ006,
        MZ003        		M/s. Neutro Pharma (Pvt.) Ltd., 9.5 Km, Sheikhupura Road, Lahore-Pakistan.
        Risk Statement:Administration of products containing bacterial endotoxins through IV infusion may lead to complications, such venous thromboembolism, septic shock etc. which may have fatal consequences.
        Action Initiated-The manufacturer has been directed to immediately recall the defective batch of product from the market. The field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of the presence and removal of the mentioned batches from the market
        -The regulatory field force of DRAP and Provincial Drug Control departments have 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/Illegal Products

          Muhammad Ayub Naveed Product Recalls
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          Rapid Alert

          DRAP Alert NoNo I/S/11-24-45
          Action Date28th November, 2024
          Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
          ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
          ·        General Public
          Problem StatementDirectorate of Drugs Control (DDC) Punjab and Secretary PQCB Quetta have informed DRAP that samples of various products have been identified as spurious (falsified). Details of test reports are as under:

          S#Product NameCompositionBatch No.Manufactured by
          (as per label claim)          		Lab Test Results
          1
          Titan-1000 Injection

          Reg# 021743          		CeIftriaxone as Ceftriaxone Sodium 1000 mg/vial 22044Purported to be manufactured by Macter International Limited (as per label claim) F-216, S.I.T.E Karachi“Spurious” and “Substandard” with regards to Assay and Sterility test,
          Dyrone Film Coated Tablet

          Reg# 198069          		Dydrogesterone DR-121Purported to be manufactured by Solvay (as per label claim), Plot # 32, Sector,2 Highway Petaro Road Jamshoro SindhSpurious
          Solverone 10 mg Film Coated Tablet

          Reg# 068898          		DydrogesteroneSVN-001Purported to be manufactured by Solvay (Fictitious firm), Plot # 32, Sector,2 Highway Petaro Road Jamshoro SindhSpurious
          Dydowen 10mg Film Coated Tablet

          Reg# 101507          		Dydrogesterone736Purported to be manufactured by Weather Folds Pharmaceuticals, Hattar, Pakistan. Manufactured For: Wenovo Pharmaceuticals TaxilaSpurious
          DYDRO-FEM 10 mg Film CoatedTablet

          Reg# 555199          		DydrogesteroneDFD10/008
          DFD10/009          		Purported to be manufactured by
          Torrent Pharmaceutical, (as per label claim) G-19, Hawkesbay Road SITE, Karachi.          		Spurious
          M.CEF 30 mL Powder For Oral Suspension

          Reg# 0432189          		Cefixime as Trihydrate 100 mg/5mLD00018Purported to be manufactured by
          Dalton Laboratories PVT LTD. (as per label claim) Plot # G-149, Phase L-II Super Highway Road,
          S.I.T.E. LI Karachi          		Spurious
          Iodex Ointment

          Reg# 000394          		Iodine + MethylsalicylateHIAACPurported to be manufactured by GSK Pakistan KarachiCounterfeit
          (Falsified)
          Risk Statement:The impact of the use of falsified / Substandard products may lead to sub-optimal therapeutic effects whereas the use of a spurious product will lead to therapy failure or other associated problems.
          Action InitiatedThe field force under the administrative control of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for the detection of the presence and removal of the mentioned batches from the market.
          Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available on this link.

          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 ConsumerConsumers 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 these 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: Recall of Substandard Flagynase Suspension (Reg. No. 087528) Batch No. 0362 Manufactured by M/s Aries Pharmaceuticals (Pvt.) Ltd, Peshawar

          Muhammad Ayub Naveed Recall Alerts

          Recall Alert

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          DRAP Alert NoNo I/S/11-24-49
          Action Date20th November, 2024.
          Target Audience– National Regulatory Field Force.
          – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
          – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
          – General Public
          Problem / Issue The Federal Inspector of Drugs, Peshawar collected the samples of Flagynase Suspension and sent for test / analysis. The Central Drugs Laboratory, Karachi has declared batch No. 0362 of the said product, manufactured by M/s Aries Pharmaceuticals (Pvt.) Ltd, Peshawar, as a Substandard product.

          Therapeutic Good(s) Affected: –

          Product NamesCompositionBatch DetailsManufactured by
          Flagynase suspension
           
          Reg. No. 087528          		Metronidazole (200mg/5ml)Batch no. 0362
          Mfg date: 10/23
          Expiry date:
          10/25          		M/s. Aries Pharmaceuticals (Pvt.) Ltd., 1-W, Industrial Estate, Hayatabad, Peshawar. 
          Risk Statement:Metronidazole Oral Suspension is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or suspected. Use of substandard products may lead to suboptimal to no-therapeutic effects and may contribute to drug resistance, and can also intensify/exacerbate the existing bacterial infection.
          Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have 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.