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Recall Alert: Drug Product; Albex 200mg Tablets (Batch#112) by M/s Swat Pharmaceuticals, Swat

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DRAP Alert NoNo II/S/09-23-34
Action Date22th Sep, 2023
Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
· Procurement Officers at Hospitals and Healthcare Institutions.
· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Albex 200mg Table
 
Reg No. 020291

Albendazole 200mgBatch No 112
 
Mfg date 04.2023
Exp date 03.2025		Ms. Swat Pharmaceutical,
Swat.
Risk Statement:Albendazole is an anthelminthic drug used to treat various parasitic worm infections. Substandard preparations of albendazole tablets may lead to treatment failure or suboptimal therapeutic effects, adverse effects, and increased antimicrobial resistance by exposing the parasitic worms to suboptimal concentrations of the drug.
Action Initiated-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. 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) has increase 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 through phone at +92 51 910 73 17, 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 this 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; Drug Product: Unregistered and Falsified Lipiodol Ultra Fluide 480mg/mL Injection

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    Rapid Alert

    DRAP Alert NoNo  I/S/09-24-37
    Action DateOctober 05, 2023
    Target Audience1. Regulatory Field Force.
    2. Healthcare Professionals – Physicians, Pharmacists, and Nurses.
    3 Procurement officer at hospitals and institutions
    4. General Public.
    Problem StatementThe regulatory field force of DRAP and the Chief Drug Inspector Office, Karachi have identified a suspected falsified lot of Lipiodol Ultra Fluide 480mg/ml Injection which was intended to supply to tertiary care hospitals. The said product is not registered in Pakistan and is not imported using special permission pathways.
    Threats to Public HealthThe use of falsified or counterfeit Lipiodol injection can pose serious health risks as it may contain unknown ingredients or no active ingredient at all. This can lead to ineffective treatment, worsening of the condition, or unexpected side effects. In some cases, falsified products have been found to contain toxic materials which expose patients to harmful substances. The safety, sterility, and quality of the falsified products referenced in this alert are also unknown.

    The product identification details are as under: –

    Therapeutic Goods Affected:-

    Product NameCompositionBatch / LotManufacture Name (as stated on label)Remarks
    Lipiodol Ultra Fluide 480mg/ml Solution for Injection (10ml)

    Registration No. Nil    		Ethiodized-oil
    (radio-opaque contrast injection)    		Batch No.: 15LU606A

    Exp. Date:
    07-2024    		Guerbet, 15 rue des Vanesses, Zone Paris Nord II FranceThe outer packaging, solution colour and consistency were different from the comparison to the original product.
    Comparison of falsified Product against the original product by G.
    Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. Since this product is not registered with DRAP, it is not permitted to be stocked or sold in pharmacies or other retail outlets. However, it is crucial for all healthcare professionals, including pharmacists and chemists, to check their stock immediately and stop the distribution or supply of this product if it is found. Information related to the supplier of this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of this product.
    Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product.

    -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.

    -Please click here for further information on problem reporting to DRAP.
    Advice for ConsumersConsumers should not use this product and should contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product, 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: Drug Product Recall: Incidents of loss and damage of vision with the off-label use of Avastin 100mg/4ml injection

    Yasir Mahmood Recall Alerts , ,

    Information Update on 3rd Nov, 2023: The recall of Avastin 100mg/4ml has been terminated based on the report of Central Drugs Laboratory, Karachi which declared the samples as of standard quality.

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    Rapid Alert

    DRAP Alert NoNo  I/S/09-24-36
    Action DateSeptember 24, 2023
    Target Audience1. Ophthalmologists and Endocrinologists
    2. Healthcare Professionals – Physicians, Pharmacists, and Nurses.
    3. Regulatory Field Force.
    4. General Public
    Problem StatementIncidents of loss of vision in diabetic patients have been reported following treatment with Altered/Dispensed/Diluted Avastin injection. This product is approved by the Drug Regulatory Authority of Pakistan (DRAP) to treat Colorectal and other metastatic carcinomas. The use of this drug product in diabetic retinopathy or other ophthalmic conditions is one of the off-label uses and is not approved by DRAP.

    The incident is linked with the alteration/dispensing/dilution and sale of Avastin 100mg/4mL Injection under unhygienic/non-sterile conditions illegally and without any Drug Sale/Dispensing License (DSL) from Provincial Health Authority by M/s Genius Advanced Pharmaceutical Services Lahore.
    Threats to Public HealthAvastin is a registered drug of M/s. Roche Pharma in Pakistan and is available in strength of 100mg/4ml and 400mg/16ml preparations. This drug is indicated for the treatment of colorectal and other metastatic carcinomas as a VGRF (vascular endothelial growth factor) inhibitor.

    However, the use in diabetic retinopathy is an off-label use to block the growth of abnormal blood vessels in the eye. Since this drug was being dispensed/diluted/repacked in 1.25mg/0.05ml dose under unhygienic conditions and in an unapproved manner, therefore, its safety cannot be ascertained which may lead to damage and loss of vision in the patients.

    The product identification details are as under: –

    Therapeutic Goods Affected:-

    Following is the detail of the alleged product:

    Product InvolvedManufacturer
    Inj. Avastin 1.25 mg/0.05ml

    Composition: Bevacizumab
    Registration No. Nil    		Genius Advanced
    Pharmaceutical Services.
    Un-registered Product

    Following is the detail of DRAP approved product:

    Product NameSuspected BatchManufacturer/Importer
    Avastin 100mg/4ml Injection


    Composition: Bevacizumab
    Registration No. 043004    		H0352B11
    B7266B20
    B7266B07    		M/s Roche Diagnostics, Germany


    Importer:
    M/s Roche Pharma, Karachi.
    Registered Product
    Action InitiatedThe Regulatory field force raided the premises of M/s Genius Advanced Pharmaceutical Services, Lahore, involved in the repacking and dispensing of Avastin injection under unhygienic/non-sterile conditions. The premises have been sealed and legal proceedings have been initiated against the personnel involved.

    The Importer of the registered product has been directed to recall the suspected batches of Avastin 100mg injection from the marked immediately. The sale/distribution of registered Avastin Injection has been put on halt till verification of its quality through sampling and laboratory testing to safeguard public health. Healthcare Professionals, Pharmacists and Chemists have been directed to stop the distribution, dispensing and administration of this product immediately, and check their stocks and stop supplying this product. The remaining stocks should be quarantined and returned to the supplier/company.
    Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities regarding the off-label use of this product.

    -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.

    -Please click here for further information on problem reporting to DRAP.
    Advice for ConsumersPatients should not use this product for any ophthalmic disease and should contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product, 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; Drug Product: Unregistered and Falsified Immune globulin Products (Hyp-Rho-D and RhoColne Injections)

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    Rapid Alert

    DRAP Alert NoNo  I/S/09-23-35
    Action DateSeptember 22, 2023
    Target Audience1. Regulatory Field Force
    2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
    3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
    4. General Public
    Problem StatementThe Regulatory field force has Identified two spurious brands of Anti-D immunoglobulin injections in the market which are not legally imported into Pakistan.

    The identified brands include Hyp-Rho-D purported to be manufactured by M/s. Woolmar Chemical Corporation USA and distributed by M/s. Zaryab Traders Lahore, and Rhocolone® 300 mcg purported to be manufactured by M/s. Bharat Serums and Vaccines Limited, India.

    The manufacturer and stated distributor of Hyp-Rho-D injection is unknown and has no legal status in the supply chain of drugs.

    Secondly, the authorized distributor of M/s. Bharat Serums and Vaccines Limited India i.e. M/s. Hakimsons (impex) (Private) Ltd., Karachi have informed us that their principal company has not supplied any batch of product Rhocolne 300mcg to Pakistan.

    The product details are as under: –

    Therapeutic Goods Affected:-

    SrProduct NameCompositionBatch #Mfg. DateExp. DateManufactured by
    (as stated on the label)
    1Hyp-Rho-D Injection
     
    Registration No: Nil
    		Rho (D) immunoglobulin (Human) for injection09181943—Jan-2025M/s. Woolmar Chemical Corporation, USA.

    Importer / Distributor:
    Ms. Zaryab Traders Lahore.
    2Rhocolne 300mcg Injection

    Registration No: Nil    		Rho (D) immunoglobulin (Human) for injection39VAN006505.11.202205.11.2022Bharat Serums & Vaccines Limited, India.
    Fig.1. Images of Falsified Hyp-Rho D Injection
    Fig. 2. Images of Falsified Rhoclone Injection
    Risk Statement:The product claimed to contain immune globulin (anti-D immune globulin or RhIG), which is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. Both of these products are unregistered which infers that the quality and safety attributes of the product are not accepted and approved by DRAP. Unregistered Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the product are unknown.
    Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate these 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 supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
    Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these products.

    -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.

    -Please click here for further information on problem reporting to DRAP.
    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 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: Drug Product; Pedolil 250mg/5mL Suspension (Batch # 167) by M/S. JASM Pharmaceutical (Pvt.) Ltd., Risalpur.

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    DRAP Alert NoNo II/S/08-23-32
    Action Date18th Sep, 2023
    Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
    · Procurement Officers at Hospitals and Healthcare Institutions.
    · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
    Problem / Issue

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch No Manufacturer
    Pedolil 250mg/5mL
    Suspension
     
    Reg No. 110389    		Paracetamol
    (Acetaminophen)    		Batch No 167
     
    Mfg. date 05.2023
    Exp. date 04.2025    		Ms. JASM Pharmaceutical
    (Pvt.) Ltd., Risalpur
    Risk Statement:Paracetamol suspension is used for mild to moderate pain and fever. Inaccurate use of the product may lead to adverse reactions including but not limited to following:
    ·         Blood disorders, such as thrombocytopenia and leukopenia.
    ·         Liver and kidney damage.
    Impact of use of substandard product on basis of deliverable volume may leads to non- uniformity of dose and may alter therapeutic effect.
    Action Initiated-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. 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) should also increase 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 through phone at +92 51 910 73 17, 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 this 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 Product; Comycetin 0.5% Eye Drops (Batch # CYF003) by M/S. Nabiqasim Industries (Pvt) Ltd., Karachi

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      DRAP Alert NoNo II/S/08-23-33
      Action Date18th Sep, 2023
      Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
      · Procurement Officers at Hospitals and Healthcare Institutions.
      · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
      Problem / Issue

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch No Manufacturer
      Comycetin 0.5% Eye Drop
       
      Reg No. 003682

      		ChloramphenicolBatch No CYF003
       
      Mfg date 02.2023
      Exp date 02.2025      		Ms. Nabiqasim Industries
      (Pvt.) Ltd., Karachi
      Risk Statement:Chloramphenicol is used to treat bacterial eye infections. The impact of use of the substandard product may lead to sub-optimal to no therapeutic effect and may intensify/flare the existing bacterial infection along with the development of Bacterial resistance.
      Action Initiated-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. 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) should also increase 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 through phone at +92 51 910 73 17, 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 this 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 Product; Kemygyl 200mg/5mL oral Suspension (Batch # M-319) by M/s. Alkemy Pharmaceutical Laboratories (Pvt) Ltd, Hyderabad

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        DRAP Alert NoNo II/S/08-23-31
        Action Date08th Sep, 2023
        Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
        · Procurement Officers at Hospitals and Healthcare Institutions.
        · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
        Problem / Issue The Provincial Government Analyst/Director, Drug Testing Laboratory, Karachi has declared the Batch No. M-319 of Kemygyl Suspension as of substandard quality sampled by Provincial Inspector of Drugs Jamshoro.

        Therapeutic Good(s) Affected: –

        Product NamesCompositionBatch No Manufacturer
        Kemygyl Suspension 200mg/5ml

        		MetronidazoleBatch No M-3019
         
        Mfg date 09.2022
         
        Exp date 08.2024        		Ms. Alkemy Pharmaceutical Laboratories (Pvt.) Ltd, Hyderabad.
        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 manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. 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) should also increase 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 through phone at +92 51 910 73 17, 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 this 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; Drug Product: Falsified Defitelio 80mg/mL Injection identified in Neighboring Countries

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          Rapid Alert

          Falsified Defitelio 80mg/mL Injection
          (Updated form WHO)

          DRAP Alert NoNo  I/S/09-23-44
          Action DateSeptember 08, 2023
          Target Audience1. Regulatory Field Force.
          2. Healthcare Professionals – Physicians, Pharmacists, and Nurses.
          3. General Public.
          Problem StatementWHO has informed regarding the presence of a falsified batch of DEFITELIO (defibrotide sodium) Lot No. 20G20A detected in India (April 2023) and Türkiye (July 2023) and was supplied outside of regulated and authorized channels. This product is not registered in Pakistan however, due to its detection in the neighboring countries, it is highly likely that this product can infiltrate the Pakistani market.
          DEFITELIO (defibrotide) is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in hematopoietic stem-cell transplantation (HSCT) therapy. It is indicated for adults, adolescents, children and infants over 1 month of age. VOD is a condition in which the veins in the liver become blocked and stops the liver from working correctly.
          The genuine manufacturer of DEFITELIO has confirmed that the product referenced in this Alert is falsified. The genuine manufacturer has advised that:
          ·         Genuine DEFITELIO with Lot 20G20A was packaged in German/Austrian packaging.
          ·         The falsified products instead are in UK/Ireland packaging.
          ·         The stated expiry date is falsified and does not comply with the registered shelf life.
          ·         The stated serial number is not associated with batch 20G20A.
          ·         DEFITELIO does not have marketing authorization in India and Türkiye.

          Therapeutic Goods Affected:-

          SrProduct NameCompositionBatch/Lot #Mfg. DateExp. DateManufactured by
          (as stated on label)
          1DEFITELIO 80 mg/mL concentrate for solution for infusion
          		Defibrotide20G20A—Aug-2024Gentium Srl
          (UK/ Ireland packaging)
          Threats to Public HealthThe use of falsified DEFITELIO will result in the ineffective treatment of patients and may pose other serious risks to health because of its intravenous administration and could be life-threatening in some circumstances. Moreover, the safety, sterility, and quality of the falsified products referenced in this alert are also unknown.
          Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. Since this product is not registered with DRAP, it is not permitted to be stocked or sold in pharmacies or other retail outlets. However, it is crucial for all healthcare professionals, including pharmacists and chemists, to check their stock immediately and stop the distribution or supply of this product if it is found. Information related to the supplier of this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of this product.
          Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products.

          -Adverse reactions or quality problems experienced with the use of this product 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 not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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.

          Pictures of Defiiteli 80mg/mL injection identified as falsified Product

          Pictures of Falsified Defitelio 80mg/mL Injection identified in Türkiye

          Recall Alert: Drug Product; Plivil 25mg Injection (Batch # 847) by M/s. Pliva Pakistan, (Pvt) Ltd, Baluchistan

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          DRAP Alert NoNo I/S/08-23-22
          Action Date06th Sep, 2023
          Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
          · Procurement Officers at Hospitals and Healthcare Institutions.
          · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
          Problem / Issue The Secretary, PQCB Baluchistan has informed DRAP that samples of Plivil Injection (Batch No. 847) manufactured by M/s. Pliva Pakistan (Pvt.) Ltd., B-77, Lasbella Industrial Estate, Baluchistan, has been analyzed by the Government Analyst, Drug Testing Laboratory (DTL), Baluchistan, Quetta and declared as Adulterated and misbranded based on analysis.

          Therapeutic Goods Affected:-

          Product NamesCompositionBatch No Manufacturer
          Plivil 25mg/ml Injection

          Reg No 021513          		Pheniramine Maleate
          25mg/ml          		Batch No 847
           
          Mfg date 02.2023
           
          Exp date 02.2025          		M/s. Pliva Pakistan (Pvt.) Ltd., Baluchistan.
          Risk Statement:Presence of foreign particles may interact within the injectable solution and may change the chemical consistency of the solution. If injected, they can cause inflammation, tissue damage, or allergic or immunogenic reactions. Additionally, unclear labels on the drug products may create difficulty in reading and understanding of drugs and may lead to medication errors such as taking the wrong medication or the wrong dose.
          Action Initiated-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. 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) should also increase 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 through phone at +92 51 910 73 17, 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 this 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; Drug Product: Unregistered and Falsified Hyp-Rho-D injection (Rho(D) immune globulin Injection

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            Rapid Alert

            Unregistered and Falsified Hyp-Rho-D injection (Rho(D) immune globulin Injection

            DRAP Alert NoNo  I/S/08-23-30
            Action DateAugust 02, 2023
            Target Audience1. Regulatory Field Force
            2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
            3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
            4. General Public
            Problem StatementThe Provincial Inspector of Drugs in Mansehra obtained a sample of the Hyp-Rho-D Injection from M/s. Abdullah Medical Store, located inside the Naseem Surgical Center, Upper Chennai Abbottabad Road, Mansehra. This particular product is not registered with the DRAP and is suspected to be falsified.
            The product detail as under: –

            Therapeutic Goods Affected:-

            SrProduct NameCompositionBatch #Mfg. DateExp. DateManufactured by
            (as stated on label)            		Remarks
            1Hyp-Rho-D Injection
             
            Registration No: Nil
            		Rho (D) immunoglobulin (Human) for injection09181943—Aug-2024M/s. Woolmar Chemical Corporation, USA.

            Importer / Distributor:
            Ms. Zaryab Traders Lahore.            		The product is not registered and is also suspected to be falsified.
            Risk Statement:The product claimed to contain immune globulin (anti-D immune globulin or RhIG), which is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. The claimed product is unregistered which infers that the quality and safety attributes of the product are not accepted and approved by DRAP. Unregistered Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the product are unknown.
            Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the 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 products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
            Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products.

            -Adverse reactions or quality problems experienced with the use of this product 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 not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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.