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Recall Alert: Medical Devices; Trifecta Family of Valves by M/s ST. Jude Medical, USA

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Recall Alert

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DRAP Alert NoNo II/S/09-23-37
Action Date10th October, 2023
Target Audience• Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Cardiologists, Pharmacists, and Nurses.
• People implanted with affected Trifecta Family Valves.
• Procurement Officers at Hospitals and Healthcare Institutions.
• Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue Abbot Structural Heart (St.Jude Medical, USA) has initiated a market withdrawal for the Trifecta family of valves (TrifectaTM Valve and TrifectaTM Valve with Glide Technology see table below) and will be removing the limited remaining inventory from the field due to potential for early Structural Valve Deterioration (SVD). Accordingly, the manufacturing company is recalling all the defective products from the international market including Pakistan. The Medical Device Board has already suspended the product registration in its 61st Meeting and further course of action for deregistration is in process under the Medical Device Rules 2017.

Therapeutic Goods Affected:-

Brand Names and DescriptionModel NoGTN/UDI Manufacturer and Distributor
TrifectaTM Valve 19mm
TrifectaTM Valve 21mm
TrifectaTM Valve 23mm
TrifectaTM Valve 25mm
TrifectaTM Valve 27mm
TrifectaTM Valve 29mm
TrifectaTM Valve with Glide Technology 19mm
TrifectaTM Valve with Glide Technology 21mm
TrifectaTM Valve with Glide Technology 23mm
TrifectaTM Valve with Glide Technology 25mm
TrifectaTM Valve with Glide Technology 27mm
TrifectaTM Valve with Glide Technology 29mm		TF-19A
TF-21A
TF-23A
TF-25A
TF-27A
TF-29A
TFGT-19A
TFGT-21A
TFGT-23A
TFGT-25A
TFGT-27A
TFGT-29A		05414734052016
05414734052023
05414734052030
05414734052047
05414734052054
05414734052061
05415067018205
05415067018212
05415067018229
05415067018236
05415067018243
05415067018250		M/s St. Jude Medical 11 county road b e saint paul, mn USA 55117
Distributor in Pakistan:
M/s Verizon, 60-D, F.C.C Zahoor Elahi Road, Gulberg-IV, Lahore.
 
Products registration no.    MDIR -0003639.
MDIR -0000233.
(Names and Models of defective products being recalled from market. For More Information please click here)
Risk Statement:The valves are intended to maximize valve opening and improve hemodynamic performance. Therefore, defective trifecta family heart valves pose a risk of patient harm which will compromise the hemodynamic performance of the valve and can lead to cardiac arrest, other serious injuries.
Action Initiated-The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed.

-All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company.

-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 these defective lots of the Medical Device. Patient using the affected device should immediately contact their doctors for further guidance. Furthermore, Abbott, USA provided patient management considerations for those patients implanted with the Trifecta and Trifecta GT valves. https://www.structuralheart.abbott/fileadmin/pdf/FINAL_Abbott_Letter_US_Trifecta_Abbott_Website_sig ned.pdf)

Understanding that clinical decisions are shared between healthcare providers and patients, please consider the following post-implant:

· Patients should be reminded to seek medical attention with new onset of symptoms such as shortness of breath or fatigue.
· An initial post-procedural transthoracic echocardiogram (TTE) study is recommended for all patients within 1 to 3 months after the implant procedure to evaluate valve hemodynamics and ventricular function.
· Schedule annual follow-up visits beginning 1-year post-implant for clinical evaluation, including TTE to assess transvalvular gradients and valvular regurgitation grade.
· Patients presenting with changes in symptoms (e.g., shortness of breath or fatigue on exertion) or signs (e.g., murmur) indicative of potential SVD should undergo a TTE.
· Patients with evidence of hemodynamically significant SVD should be considered, in consultation with a heart team, for a possible valve intervention with either surgical aortic valve replacement (SAVR) or a trans catheter valve-in-valve intervention depending on individual patient risks and benefits.
· Patients being considered for a valve-in-valve intervention should undergo pre-procedure planning with imaging studies to ensure all potential procedure-related risks such as coronary obstruction are minimized. Additional information regarding future valve-in-valve considerations can be found in the Trifecta GT valve IFU. Please note that the titanium frame of the Trifecta GT valve cannot be fractured using a balloon. Actions Abbott is Asking You to Take:
· Please consider this information in your practice and share with relevant health care professionals (e.g., cardiac surgeons, cardiologists, primary care physicians) involved in the care of patients implanted with the Trifecta family of valves in your institution.
· Complete and return the provided Acknowledgement Form.
· Report any product incidents, regardless of procedure or patient outcome, to Abbott.

-Adverse reactions or quality problems experienced with this product may 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 Consumers-Consumers should stop using this product bearing the affected Model no and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to using this Medical Device and report the incident to National Pharmacovigilance Centre of Drug Regulatory Authority of Pakistan, through MedSafety Mobile Application, or online at Med Vigilance E Reporting System.

-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; Albex 200mg Tablets (Batch#112) by M/s Swat Pharmaceuticals, Swat

    Asad Ullah Recall Alerts

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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

        Asad Ullah Recall Alerts

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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

            Asad Ullah Recall Alerts

            Recall Alert

            Download

            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.