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Recall Alert: Drug Product; Promass 1g/100mL Inf by M/s Treat Pharmaceutical, Bannu

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DRAP Alert NoNo I/S/09-24-34
Action Date23rd September 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 Drug Inspector, Dera Ismail Khan, KPK collected the samples of Promass 1g Infusion and sent for analysis. The provincial Drug Testing Laboratory, KPK, Peshawar has declared batch No 034 of Promass 11g Inf, manufactured by the M/s Treat Pharmaceutical Industry, Bannu, as a substandard product.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Promass 1gm/100ml Inf

Reg.No. 075336
ParacetamolBatch No. 034
 
Mfg Date:01-07-2023
Exp Date:30-06-2025		M/s. Treat Pharmaceutical
Industry (Pvt.) Ltd, Kohat Road, Bannu
Risk Statement:Identification of visible particles in infusion products is a serious indicator of substandard quality, which can lead to significant health risks including severe reactions such as shivering, high fever, arterial blockages, infarction and more serious adverse events.
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 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.

    Rapid Alert: Recall of Contaminated Liquid Preparations

    Asad Ullah Recall Alerts

    Rapid Alert

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    DRAP Alert NoNo I/S/09-24-33
    Action Date10th September 2024
    Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
    ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
    · General Public
    Problem / Issue The Directorate of Drugs Control (DDC), Punjab has identified contamination of Ethylene Glycol in following liquid preparations. Drug Testing Laboratories (DTLs) have declared these batches of products as Substandard based on their analysis which revealed the presence of Ethylene Glycol exceeding limits. T

    Therapeutic Good(s) Affected: –

    The details of the affected batches are as follows:

    S#Product NameCompositionBatch No.Manufactured by
    01Texcol EX Syrup 120ml   Reg. No. 030897Aceylline Piperazine 45mg/5ml, Diphenhydramine HCl 8mg/5ml63864M/s. Razee Therapeutics (Pvt.) Ltd., Lahore
    02Speczine Syrup 120ml   Reg. No. 012597Promethazine HCl 5mg/5ml609 604 YZM/s. Spectrum Laboratories, Lahore
    03Mexair Syrup 60ml   Reg. No. 02665Terbutaline Sulphate 1.5mg/5ml05-23 02-22M/s. Siza Int., Lahore
    04Stazin Syrup 60ml   Reg. no. 026326Cetrizine HCl 5mg/5mlGI 83M/s. Munawar Pharma (Pvt.) Ltd., Lahore
    05Zevirol Expectorant syrup 120ml
    Reg. No. 009378    		Dipenhydramine HCl 13.5mg, Ammonium Chloride 131.5mg, sodium citrate 55mg, Menthol 1mg4031P.D.H. Laboratories Lahore
    06Stazin Syrup 60ml   Reg. No. 026326Cetrizine HCl 5mg/5mlGI83M/s. Munawar Pharma Lahore
    07Zevirol Expectorant syrup 120ml   Reg. No. 009.78Diphenhydramine 13.5mg, Ammonium Choride 131.5mg4031M/s. P.D.H. Pharmaceuticals Lahore
    08Aphylin Expectorant Syrup   Reg. No. 026635Aminophylline 32mg/5ml, Diphenhydramine 8mg/5ml, Amonium Chloride 30mg/5ml24C090M/s. Obsons Pharmaceuticals Lahore
    09Resfyl Syrup   Reg. No. 057214Acefylline Piperzine 45mg/5ml,
    Diphenhydramine 8mg/5ml    		4A055M/s. Rasco Pharma Lahore
    10Zonid Suspension 120ml   Reg. No. 022579Metronidazole 200mg/5mlZ492 Z246M/s. Bloom Pharmaceuticals Hattar
    11Butamin Syrup 60ml   Reg. No. 016630Salbutamol 2mg4016M/s. P.D.H Pharmaceuticals, Lahore
    12Nuocid Plus suspension 120ml   Enlst. No. 0327660558Zingiber Officinale 20mg/5ml, Mentha Piperita 40mg/5mlNC-S045M/s. Arber Pharma Lahore

    Risk StatementDi-ethylene Glycol (DEG) and Ethylene Glycol (EG) contaminated oral preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences
    Action Initiated-The manufacturers of products have been directed to immediately recall the defective batches of from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks 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.

    -The 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 batches of liquid products.  

    -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: Recall of Contaminated Liquid Preparations

      Asad Ullah Recall Alerts

      Rapid Alert

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      DRAP Alert NoNo I/S/09-24-32
      Action Date06th September 2024
      Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
      ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
      · General Public
      Problem / Issue The Directorate of Drugs Control (DDC), Punjab has identified contamination with ethylene glycol and diethylene glycol in the following liquid preparations. Analysis from Drug Testing Laboratories (DTLs) has declared these products as Substandard

      Therapeutic Good(s) Affected: –

      The details of the affected batches are as follows:

      S#Product NameCompositionBatch No.Manufactured by
      01Cestonil Plus syrup   Reg. No. 021843Thiamine 1.75mg, Riboflavin 2.62mg, Pyridoxine 1.54mg, Nicotinamide 10.50mg061357M/s. Razzee Therapeutics, Lahore
      02Texcol DM 10mg/5ml syrup   Reg. No. 025034Dextromethorphan09980M/s. Razzee Therapeutics, Lahore
      03Speczine 5mg/5ml Syrup   Reg. No. 012597Promethazine280 287M/s. Spectrum Laboratories, Lahore
      04Aphylin Syrup   Reg. No. 026635Aminophylline 32mg, Diphenhydramine 8mg, Ammonium HCl 30mg24B056M/s. Obsons Pharmaceuticals, Lahore
      05Zolint Suspension   Reg. No. 016494Furazolidone 25mg/5ml, Metronidazole 75mg/5ml24003M/s. Libra Private Ltd., Peshawar
      Risk StatementDi-ethylene Glycol (DEG) and Ethylene Glycol (EG) contaminated oral preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences
      Action Initiated-All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks 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.

      -The 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 batches of liquid products.  

      -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: Crackdown Against Spurious/Falsified Drug Products

        Asad Ullah Recall Alerts
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        Rapid Alert

        DRAP Alert NoNo I/S/09-24-31
        Action Date06th September 2024
        Target Audience·         Regulatory Field Force.
        ·         Healthcare Professionals – Physicians, Pharmacists, and Nurses.
        ·         Procurement Managers at Hospitals, Clinics, Pharmacies and other Healthcare Institutions
        ·         General Public.
        Problem StatementThe Directorate of Drugs Control (DDC) Punjab has detected the following falsified drug products based on their analysis from Drug Testing Laboratories (DTLs).

        The details of the identified products are as under: –

        S#Product NameCompositionBatch No.Manufactured by
        (as stated on the label)        		Test Results
        01Ativan 2mg TabletsLorazepam17C7019Purported to be manufactured by M/s. Pfizer Pakistan, KarachiSpurious
        02Marfix 400mg TabletCefiximeMK-0002M/s. Mirak Pharmaceutical, LahoreSpurious
        03Payodine 10g/100ml SolutionPovidone-Iodine002709M/s. A.Mannan Lab, KarachiSpurious
        04Froxime 400mg CapsuleCefiximeFRX-400/C-6M/s. Froxx Pharmaceuticals, KarachiSpurious & Misbranded
        05Noa-Xime 400mg CapsuleCefiximenx-00525-02M/s. Noa Hemis Pharmaceuticals, KarachiSpurious & Misbranded
        06Biovim InjectionBenzyl Penicillin 500000 IU, Procaine Penicillin 1500000 IUC. B-86M/s. Uniline Pharma, KarachiSpurious
        07Novazone Plus DrenchOxyclonazde 3% w/v, Levamisole HCl1.5% w/v, Cobalt Sulphate 0.075% /v, Selenium Selenite 0.035%061M/s. Uniline Pharma, KarachiSpurious
        Note: The red color font in the table indicates fake products and manufacturers’ names. These are not licensed or registered by DRAP. 
        Threat to Public HealthSpurious or falsified pharmaceuticals may contain harmful levels of toxic substances, posing a significant risk of widespread poisoning. These substandard medications have the potential to undermine the efficacy of disease treatment and exacerbate preexisting medical conditions. The safety and quality of the falsified products referenced in this alert are 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. 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 to halt the distribution/supply of this product. 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 these products.
        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 Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

        -Please click here for further information on problem reporting to DRAP.
        Advice for ConsumersConsumers should stop using this product and shall contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the 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 Products; Recall of 11 Substandard Batches from the Market

        Asad Ullah Recall Alerts

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        DRAP Alert NoNo I/S/09-24-30
        Action Date06th September 2024.
        Target Audience– National Regulatory Field Force.
        – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
        – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics
        – General Public
        Problem / Issue The Directorate of Drugs Control (DDC) in Punjab and the Quality Control Board in Baluchistan have identified the following substandard batches of pharmaceutical products based on analyzing their samples from Drug Testing Laboratories, revealing out-of-specification results.
        The Details of affected product batches is tabulated below        :-

        Therapeutic Good(s) Affected: –

        S#Product NameActive IngredientsBatch No.Manufactured byTest Results
        01Zyocain gel 15gLidocaine HCL 2%244
        275        		M/s. Pharmawise Laboratories, LahoreSubstandard
        02Metrorise injectionMetronidazole 500mg/100mlLV 2303M/s. Pak risen Pharmaceuticals, HattarSubstandard
        03Safemed InjectionMetronidazole 500mg/100mlS-825M/s. Ahad International Pharmaceutical Ltd., DI KhanSubstandard
        04Lyosafe InfusionLevofloxacinL-784M/s. Ahad International Pharmaceutical Ltd., DI KhanSubstandard
        05Enzol-WFI injection  Sterile water for injection1240003M/s. Enzon Pharma, LahoreSubstandard
        06Oxytofas InjectionOxytocinOTI-1419M/s. Intervac (Pvt.) Ltd., SheikhupuraSubstandard &Misbranded
        07Painsa 75mg InjectionDiclofenac SodiumPA420M/s. Wimits Pharmaceuticals, LahoreSubstandard
        08Midoven InjectionFurosemideH-21924M/s. Venus Pharma, LahoreAdulterated
        09Mencobal InjectionMecobalamin083
        084        		M/s. Treat Pharmaceutical Industry, LahoreAdulterated
        Action Initiated–The manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned 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, by phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk.

        -The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased market surveillance 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 products 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: Falsified Propylene Glycol in Supply Chain Market

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          Rapid Alert

          DRAP Alert NoNo  II/S/08-24-29
          Action Date22nd August 2024
          Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control Administrations
          2. Therapeutic Goods Manufacturers
          Problem StatementDow Chemical’s Singapore and the Incidents and Substandard/Falsified Medical Products (ISF) Regulation and Safety Unit, World Health Organization have informed DRAP that some miscreants are supplying falsified batches of Propylene Glycol with counterfeit Dow Chemical labelling in the supply chain market in Pakistan. The quality and safety of this material cannot be assured, and it should not be used in the manufacture of medical products.

          Details of identified falsified batches are as under:_

          Material Batch/Lot No.Manufacturer (as stated on the label)Mfg. DateExp. Date
          Propylene Glycol USP/EPF9600L7PPA4Dow Europe GmbH18-10-202318-10-2025
          Propylene Glycol US/EPF8900L8PPD6Dow Europe GmbHFeb-2023Feb-2025
          USP PropyleneSS8900B3PPD5The Dow Chemical Company18/May/2023-Nil-
          Please see the attached alert for pictures of falsified containers of Propylene Glycol
          Risk Statement:Diethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
          Action Initiated: –The Regulatory Field Force has taken possession of contaminated raw materials and commenced an investigation to trace the supply chain of these containers. Manufacturers of therapeutic goods have been prohibited from using propylene glycol without testing for the presence of EG/DEG levels. These materials should only be obtained from authorized suppliers of original manufacturers with thorough verification of the integrity of the supply chain and originality of the product. The Regulatory Field Force has also been directed to ensure compliance and seize any such raw materials or products found to be contaminated in the market.
          Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
           
          1.      Recall Products: If any batch of finished product has been manufactured using the same batch of the propylene glycol that has been identified as contaminated, the retained sample should be immediately analysed and these finished products should be recalled from local and export markets if found contaminated.


          2       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.

          3.     Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

          4.    Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

          5.     Follow Guidelines: Adhere to the pharmacopeial monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.

          Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
          Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of 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 centres.

          -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

          -Please click here for further information on problem reporting to DRAP.
          Advice for ConsumersConsumers should stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

          All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

          Recall Alert: Drug Products; Recall of 12 Substandard Batches from the Market

          Asad Ullah Recall Alerts

          Recall Alert

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          DRAP Alert NoNo I/S/05-24-28
          Action Date14th June 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 Directorate of Drugs Control (DDC) Punjab vide Alert No. 137/2024 and 135/2024 has informed that the following samples of drug products have been declared as Substandard by Drug Testing Laboratories (DTL). The Details of affected product batches is tabulated below.

          Therapeutic Good(s) Affected: –

          S#Product NameCompositionBatch No.Manufactured byTest Results  
          01Metroin 100ml infusionMetronidazoleMT23-014M/s. Saturn Pharmaceuticals, Lahore.Substandard
          02Tozen-D Ophthalmic SuspensionTobramycin and DexamethasoneTW019M/s. Epharm Laboratories, Karachi.Substandard
          03Ann-Vil 50ml InjectionPheniramine MaleateV-44423M/s. Venus Pharma, Lahore.Substandard
          04Arpes 500mg Powder for InjectionAcyclovirAR-099M/s. MTI Medical, Lahore.Substandard
          05Torax 60ml SyrupAcefylline Piperazine and Diphenhydramine24-24M/s. Siza International, Lahore.Unacceptable Ethylene Glycol level identified
          06Zonid 200mg/5ml syrup 120ml Metronidazole BenzoateZ396
          Z244
          Z243
          Z413
          Z398
          Z414
          Z397          		M/s. Bloom Pharmaceuticals, Hattar.Unacceptable Ethylene Glycol level identified
          Action Initiated–The manufacturers have been directed to immediately recall the defected batches of their products from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of abovementioned 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 this defective batch of the product.  

          -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the           Adverse Event Reporting Form or online through this link.

          -Please click here for further information on problem reporting to DRAP.
          Advice for Consumers-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

          -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

            Rapid Alert: Crackdown Against Spurious/falsified Drug Products

            Asad Ullah Recall Alerts
            Download

            Rapid Alert

            DRAP Alert NoNo I/S/06-24-27
            Action Date14th June 2024
            Target Audience·         Regulatory Field Force.
            ·         Healthcare Professionals – Physicians, Pharmacists, and Nurses.
            ·         Procurement Managers at Hospitals, Clinics, Pharmacies and other Healthcare Institutions
            ·         General Public.
            Problem StatementThe Directorate of Drugs Control (DDC) Punjab vide Alert No. 137/2024 has informed that the following samples of drug products have been declared as “Spurious” by Drug Testing Laboratories (DTL) Multan, Lahore, Rawalpindi, and Faisalabad. Details of affected products are as follows:.

            The details of affected products and their batches are as under: –

            S#Product NameBatch No.Purported to be Manufactured by
            (as per label)            		Batch No.
            01Powder Amox 500 (1kg)

            (veterinary use)            		0010823Imported by: M/s. Brand Station, Lahore.
            Mfg. by: M/s. The North Star Import Export
            Joint Stock Company, Can Tho City, Vietnam.            		Spurious
            02Nutricare Syrup 450mlNC-457M/s. Care Pharmaceuticals.Spurious
            03Velosef 500mg Capsule847MM/s. GSK, Karachi.Spurious
            04Pyodine Solution 60ml04813M/s. Brookes Pharma, Karachi.Spurious
            05Pyodine Solution 450ml08913M/s. Brookes Pharma, Karachi.Spurious
            06Tanzo 0.5g InjectionPN220142M/s. Bosch Pharmaceuticals, Karachi.Spurious
            07Dydowen 10mg Tablet736M/s. Weather Fold Pharmaceuticals, Hattar.Spurious
            08Duphaston 10mg Tablet230672
            230092            		Mfg. by: Highnoon Laboratories Lahore.
            Mfg for: Abbott Laboratories, Karachi.            		Spurious
            09Cefspan 400mg CapsuleD6780M/s. Barrett Hodgson Pakistan, Karachi.Spurious
            10Phenobar 30mg TabletQA023M/s. Star Laboratories, Lahore.Spurious
            Threat to Public HealthSpurious or falsified pharmaceuticals may contain harmful levels of toxic substances, posing a significant risk of widespread poisoning. These substandard medications have the potential to undermine the efficacy of disease treatment and exacerbate preexisting medical conditions. The safety and quality of the falsified products referenced in this alert is 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. 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 to halt the distribution/supply of this product. 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 Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

            -Please click here for further information on problem reporting to DRAP.
            Advice for ConsumersConsumers should stop using this product and shall contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the 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: Busting of Illegal Manufacturing Site producing Unregistered Boostin (RBST) Injections

            Asad Ullah Recall Alerts
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            Rapid Alert

            DRAP Alert NoNo I/S/05-24-25
            Action Date10th June 2024
            Target Audience·         National Regulatory Field Force.
            ·         Distribution, Pharmacies and Medical Stores
            ·         Healthcare Professionals – Veterinarians, Chemists
            ·         Farmers/Consumers 
            Problem StatementDuring a joint raid by DRAP and FIA, illegal manufacturing of Boostin Injections (Synthetic Recombinant Bovine Somatotropin Hormone) was unearthed at Chandio Village, Clifton, Karachi. A large quantity of raw materials used in the manufacturing of Boostin Plus 2g Injections, finished goods, empty cartridges/containers with needles, packing materials/stickers, and packing machinery were seized from the premises as per Form-2 under Section 18(1) of the Drug Act 1976.
            Threat to Public HealthRBST (a synthetic recombinant Bovine Somatotropin hormone) injected into animals for enhancing their milk production was banned in the country due to serious side effects on health of animals and impact on those consuming milk and meat of such animals. The product is also banned in Europe, Canada, Australia etc.
            Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities in markets to confiscate the product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force in order to ensure the removal of this products. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of this product.
            Advice for VeterinarianDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link
            Advice for Farmers/ConsumerFarmers/Consumers should not use this product. They shall contact their physician or healthcare provider(s) if the animal experienced any problem that may be related to using this product.

            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; Water for Injection (Batch 989) by Zafa Pharmaceutical Pvt Ltd, Karachi

            Asad Ullah Recall Alerts

            Recall Alert

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            DRAP Alert NoNo I/S/06-24-26
            Action Date09th June 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 Drug Inspector in Karachi collected a sample of Sterile Water for Injection and sent for laboratory analysis. Federal Government Analyst at CDL Karachi has declared Batch No. 989 of the product as substandard.

            Therapeutic Good(s) Affected: –

            Product NamesCompositionBatch DetailsManufactured by
            Sterile Water for Injection

            Reg No. 030217
            		Water for InjectionBatch No. 989
             
            Mfg Date:03-2023
            Exp Date:03-2028            		M/s. Zafa Pharmaceutical
            Laboratories Private Limited Karachi.
            Risk Statement:Using non-sterile water for reconstitution of injectable medications can lead to bacterial and fungal infections, and may cause poor dissolution of the powder. It could also result in precipitation or deactivation of the active pharmaceutical ingredient, posing significant health risks.
            Action Initiated–The manufacturer has been directed to immediately recall the defected batch of product from the market. All pharmacists and chemist 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. 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 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 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.