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Recall Alert: Substandard Product “Heparin-Indar Solution for Injection 5ml” Batch No. 64B0223B Mfg. By PRJSC <INDAR> Ukraine.

Muhammad Ayub Naveed Uncategorized

Recall Alert

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DRAP Alert NoNo I/S/01-25-11
Action Date16th January 2025.
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 Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples of below product have been reported as substandard by Drug Testing Laboratory (DTL) Lahore:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Heparin-Indar solution for injection 5ml

(Heparin Sodium 2000IU/ml)Batch No.
64B0223B		PRJSC <Indar>, Ukraine, 02099, Kyiv, 5 Zeoshyvalna Str.
Risk Statement:The use of substandard injections may pose serious health risks to patients, including reduced efficacy or lack of therapeutic effect and increased risk of adverse drug reactions such as allergic reactions, anaphylaxis, and hypersensitivity reactions.
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 Product “Sterile Water for Injection 5ml” Batch No. 224 Mfg. By M/s Pharmedic Laboratories (Pvt.) Ltd., Lahore

    Muhammad Ayub Naveed Uncategorized

    Recall Alert

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    DRAP Alert NoNo I/S/01-25-06
    Action Date05th January 2025.
    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 Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples below product has been reported substandard by Drug Testing Laboratory (DTL) Lahore:

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by
    Sterile Water for Injection, 5mlSterile Water for Injection,Batch no. 224
    		Pharmedic Laboratories, Lahore
    Risk Statement:
    The use of substandard injections may pose serious health risks to patients, including reduced efficacy or lack of therapeutic effect and increased risk of adverse drug reactions such as allergic reactions, anaphylaxis, and hypersensitivity reactions    .
    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 Substandard Folic Acid Tablet Batches (490, 612) Manufactured By M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi.Recall Alert:

      Muhammad Ayub Naveed Uncategorized

      Recall Alert

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      DRAP Alert NoNo I/S/12-24-56
      Action Date18th 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 The Provincial Inspector of Drugs of various districts of Balochistan collected the samples of Folic acid Tablet and sent for test / analysis. The Drug Testing Laboratory, Quetta has declared following batches of Folic acid Tablet, manufactured by M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi, as of substandard quality based on uniformity of weight:

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by
      Tablet Folic Acid
      Reg. No. 000859      		Folic acid 5 mgBatch No. 490
      Batch No. 612      		M/s. Zafa Pharmaceutical Laboratories (Pvt.) Ltd. 4/1, A&B, Block-21, Federal “B” Industrial Area, Karachi-75950 
      Risk Statement:Folic Acid Tablets not complying with the uniformity of weight specification could result in inconsistent dosages of the active pharmaceutical ingredient (API), potentially leading to reduced therapeutic efficacy or an increased risk of adverse effects in patients.
      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 Dexyken 300 mg Tablet Batch No. Kf23006  Manufactured By M/s. Kanel Pharma, Plot 6, Street SS-3, Rawat Industrial Estate, Islamabad

        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: 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.

            Recall Alert: Drug Products; Recall of 02 Substandard Batches Manufactured by M/s Gulf Pharmaceuticals from the Market

            Asad Ullah Product Recalls, Recall Alerts, Uncategorized

            Recall Alert

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            DRAP Alert NoNo I/S/11-24-47
            Action Date08th 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 Federal Government Analyst, CDL Karachi vide test report No. IP-9-24-000082 dated 15-10-2024 has declared the product namely Hi-Z syrup batch No. S1427 as of substandard quality. Details of CDL test report are as under:

            Therapeutic Good(s) Affected: –

            Product NamesCompositionBatch DetailsManufactured by
            Hi-Z syrup

            (Reg. no. 075129)            		20mg Elemental Zinc/5mlBatch No. S1427
             
            Mfg Date: 07-2024
            Exp Date: 06-20226            		M/s. Gulf Pharmaceuticals, Islamabad
            Ufen Oral Suspension

            (Reg. No. 090274)            		100mg Ibuprofen/5mlBatch No. S1451
             
            Mfg Date: 08-2024
            Exp Date: 07-20226            		M/s. Gulf Pharmaceuticals, Islamabad
            Risk Statement:Elemental Zinc syrups are used for reduction of duration and severity of diarrhea in children who are undernourished. Moreover, in patients suffering from Wilson disease, taking zinc by mouth improves symptoms by blocking how much copper is absorbed and increases how much copper the body releases. Sub-standard Zinc preparations may lead to complications in above mentioned conditions.
            Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce fever, pain, and inflammation. Altered pH of an oral preparation may lead to gastrointestinal irritability, decreased stability and altered absorption of the product. These factors can ultimately lead to the therapy failure.
            Action Initiated–The manufacturer has been directed to immediately recall the defective batches of products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of products. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) also increased surveillance in the market to ensure the effective recall of defective products(s).

            –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.

              Decisions of 72nd Meeting of Medical Device Board; Deficiency letters for Medical Devices Applications

              Asad Ullah Medical Devices Board, Uncategorized

              The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 72nd meeting has deferred the following applications of registration/enlistment of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment.

              72nd Meeting MDBDownload

              Rapid Alert: Contaminated Lot of Sorbitol Identified in Karachi

              Asad Ullah Uncategorized
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              Rapid Alert

              DRAP Alert NoNo  II/S/04-24-19
              Action Date15th May 2024
              Target Audience·         Regulatory Field Force.
              ·         Therapeutic Goods industry
              ·         Manufactures of Oral liquid preparations
              Problem StatementThe Federal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis report No. RM-2-24-000136 dated 22-03-2024 declared the sample of Sorbitol (Batch 09-LM-023) sent to CDL Karachi by M/s. Herbiotics Healthcare Rawalpindi in compliance to letter vide No. 03-41/2023-QC dated 01-12-2023.

              Details of CDL test/analysis report are as under:

              Product NameManufacturer as per labelBatch No.Test ResultsLimits
              Sorbitol  M/s. Master Sweetener, Karachi09-LM-023Ethylene Glycol: 0.6431% Does not complyEthylene Glycol: NMT 0.1%  
              Risk Statement:Ethylene Glycol (EG) contaminated raw materials when used in oral liquid preparations can lead to serious health risks. When ingested, EG is 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 Initiated: –The therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of Sorbitol. The Regulatory Field Force has also been instructed to seize all preparations manufactured using the same batch of Sorbitol if found in the market.
              Advice for Therapeutic Goods Manufacturers: –Manufacturers of therapeutic goods are required to follow these instructions:
               
              1.      Recall Products: If any batch was manufactured using the same lot of Sorbitol 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 same lot of sorbitol 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 Professionals: –DRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of DEG/EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centers.
              Adverse reactions 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.  Further information on reporting problems to DRAP is available on this link.