Home > Safety Info > Product Recalls

Product Recalls

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

Asad Ullah Product Recalls, Recall Alerts, Uncategorized

Recall Alert

Download

DRAP Alert NoNo I/S/11-24-47
Action Date08th November, 2024.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
– General Public
Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. IP-9-24-000082 dated 15-10-2024 has declared the product namely Hi-Z syrup batch No. S1427 as of substandard quality. Details of CDL test report are as under:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Hi-Z syrup

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

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

–Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk.

–Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

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

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

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

    Rapid Alert: Falsified Rhophylac 300mcg PFS, Human Anti-D Immunoglobulin Injection Identified in Market

    Asad Ullah Recall Alerts
    Download

    Rapid Alert

    DRAP Alert NoNo I/S/11-24-42
    Action Date07th November, 2024
    Target Audience·         National Regulatory Field Force.
    ·         Distribution, Pharmacies and Medical Stores
    ·         Healthcare Professionals – Physician, Pharmacist, Nurses
    · Maternal and Child Health Centres
    Problem StatementM/s Hakimsons Impex (Private) Ltd, Karachi, has notified DRAP regarding the presence of falsified Rhophylac 300mcg PFS in the market across Pakistan and also referred to letter No. 438/PDI-ZR/PWR, received from Provincial Inspector, Peshawar for verification of the sample. The packaging of the product shows two different batch numbers while barcode scan displays another batch number.
    Product nameBatch/Lot No.Manufacturer Name
    (as per label)     		Mfg. dateExp. date
    Rhophylac 300mcg PFS,
    Human Anti-D Immunoglobulin    		P100547971
    P100644011
    ­­­­
    Barcode Batch:
    P100585096    		M/s CSL Behring AG,
    Wankdorfstrasse 10,
    CH-3000 Bern 22,Switzerland.     		10-202309-2026
    Threat to Public HealthThe Anti-D immunoglobulin 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. Falsified Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the products are unknown
    Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities in market to confiscate the product. All pharmacists and chemist working at distributions and pharmacies are once again directed to not procure / supply unregistered drugs. The stocks of any suspected should be quarantined and supplier’s information should be provided to the Regulatory field force in order to ensure the removal of this product. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of any unregistered product
    Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link.

    Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link
    Advice for ConsumerConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using these products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

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

    Voluntary Recall Alert: Drug Product; Neo-Pyrolate Injection (Batch # 105B24) Manufactured by M/s Brookes Pharma (Pvt.) Ltd, Karachi.

    Asad Ullah Recall Alerts

    Recall Alert

    Download

    DRAP Alert NoNo I/S/11-24-46
    Action Date28th October 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 M/s. Brookes Pharma Private Limited, Karachi, has initiated a voluntary recall of voluntary recall of the following product through public notice. The details of the product are as below:

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by
    Neo-pyrolate Injection IV
     
    1ml × 10’s    		Glycopyrrolate + Neostigmine MethylsulphateBatch No. 105B24
     
    Mfg. date: 02-2024
    Exp. date: 02-2026    		M/s Brookes Pharma (Pvt.) Ltd, Karachi.
    Risk Statement:The use of substandard injection may pose serious health risks to patients, including reduced efficacy or lack of therapeutic effect and increased risk of adverse drug reactions such as allergic reactions, anaphylaxis, and hypersensitivity reactions.
    Action InitiatedThe field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to conduct market surveillance for the detection of the presence and removal of the recalled batches from the market.
    Advice for Healthcare ProfessionalsAll pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the mentioned product. The remaining stocks 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).  

    -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 products bearing the affected batch number(s) and should 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 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; Famila 150mg Injection (Batch # 083) By Zafa Pharmaceutical Laboratories, Karachi

      Asad Ullah Recall Alerts

      Recall Alert

      Download

      DRAP Alert NoNo I/S/10-24-41
      Action Date24th October 2024.
      Target Audience– National Regulatory Field Force.
      – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
      – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
      – General Public
      Problem / Issue The Federal Inspector of Drugs, Karachi collected the samples of Famila 150mg Injection and sent for test / analysis. The Central Drugs Laboratory, Karachi has declared batch No. 083 of Famila Injection, manufactured by M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi, as a substandard product.

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by
      Famila 150mg Injection

      Reg.No. 015615
      		Medroxyprogesterone
      acetate      		Batch No. 083
       
      Mfg Date: 02-2023
      Exp Date: 02-2029      		M/s. Zafa Pharmaceutical
      Laboratories, Karachi
      Risk Statement:To comply with the Sterility testing for injections is crucial to ensure that the product is free from viable microorganisms. The samples of above mentioned product have been reported substandard based on sterility. The use of the said medicine may lead to transmission of blood borne infections and 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: Contaminated Propylene Glycol (Batch# YF01230522)

        Asad Ullah Recall Alerts
        Download

        Rapid Alert

        DRAP Alert NoNo  I/S/10-24-38
        Action Date25th October, 2024
        Target Audience1. Regulatory Field Force.
        2. Therapeutic Goods industry
        3. Manufactures of Oral liquid preparations
        4. Healthcare professionals
        Problem StatementThe Federal Government Analyst at Central Drugs Laboratory (CDL) Karachi has identified a contaminated batch of Propylene Glycol which has been declared substandard vide Report No. RM-8-24-000486 dated 19-09-2024. Samples of this Propylene Glycol (Raw material) were sent to CDL Karachi by a licensed pharmaceutical manufacturer in compliance with DRAP advisory on solvent testing. The manufacturer has been stopped from using the contaminated material and its supply chain is under investigation.

        The product identification details are as under: –

        Therapeutic Good Affected:-

        ProductBatch No*Mfg DateExp. DateManufacturer Name
        (as per label)        		Remarks
        Mono Propylene Glycol
        (Raw Material)        		YF0123052222-May-202321-May-2025M/s. Dongying Hi-Tech Spring Chemical Industry Co. Ltd., China.
        [The material found in the packaging with the label of this manufacturer, however product authenticity and supply chain integrity are under investigation and yet not confirmed.]        		The sample is declared substandard
        due to conatmination of Ethylene Glycol.

        Note: On February 13, 2024, DRAP issued a Rapid Alert regarding contaminated Propylene Glycol (Batch #1P03-202308194). The investigation revealed that a falsified product had been packaged and labelled as being manufactured by Dongying Hi-Tech Spring Chemical Industry Co., Ltd. in China. The manufacturer also provided Certificate of Analysis (CoAs) to DRAP showing that the original product was not contaminated and analysis of retained samples met all required specifications.

        Risk StatementDi-Ethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
        Action InitiatedThe manufacturer has been instructed to halt the consumption of the contaminated material, and an investigation into the supply chain is underway. The Regulatory Field Force has increased surveillance to identify the contaminated batch of Propylene Glycol in the market. DRAP has strictly prohibited manufacturers of therapeutic goods from using Propylene Glycol without testing for Ethylene Glycol (EG) and Diethylene Glycol (DEG) levels.
        Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
         
        1.      Recall Products: If any batch was manufactured using the same lot of Propylene Glycol that has been identified as contaminated, all finished products from local and export markets should be recalled.
        2.      Hold Other Batches: All finished products manufactured from the same lot of propylene glycol should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain.
        3.      Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.
        4.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.
        5.      Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.

        Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
        Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres.

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

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

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

        Rapid Alert: Unregistered and Falsified RBST Injection Confiscated

        Asad Ullah Recall Alerts
        Download

        Rapid Alert

        DRAP Alert NoNo I/S/10-24-40
        Action Date24th October 2024
        Target Audience·         National Regulatory Field Force.
        ·         Distribution, Pharmacies and Medical Stores
        ·         Healthcare Professionals – Veterinarians, Chemists
        ·         Farmers/Consumers 
        Problem StatementFederal Inspector of Drugs, Karachi alongwith FIA conducted a raid at premises of M/s Bismillah Medical Store, District Malir, Karachi and the following unregistered products/Stock was seized from the premises as per Form-2 under Section 18(1) of Drugs Act, 1976.
        Product nameBatch/Lot No.Manufacturer Name
        (as per label)         		Mfg. dateExp. date
        Boostin Injection
        (Recombinant Bovine Somatropin)

        Reg. No. Nil        		BSS22100M/s LG Chem, Korea.   30-05-202329-05-2026
        Threat to Public HealthRecombinant Bovine Somatotropin hormone is 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 market to confiscate the product. All pharmacists and chemist working at distributions and pharmacies are once again directed to not procure / supply unregistered drugs. The stocks of any suspected should be quarantined and supplier’s information should be provided to the Regulatory field force in order to ensure the removal of this product. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of any unregistered 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 Products; Recall of 04 Substandard Batches from the Market

        Asad Ullah Recall Alerts

        Recall Alert

        Download

        DRAP Alert NoNo I/S/10-24-39
        Action Date25th October 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) Punjab has informed DRAP that samples of the following products have been identified as contaminated with DEG/EG impurities based on analysis conducted by the Drug Testing Laboratories Punjab.
        The Details of affected product batches are tabulated below        :-

        Therapeutic Good(s) Affected: –

        S#Product NameCompositionBatch No.Manufactured byTest Results  
        01Zonid Suspension 120ml Reg# 022579Metronidazole 200mg/5mlZ266M/s. Bloom Pharmaceuticals (Pvt.) Ltd., Hattar.Contains Ethylene Glycol Above Permissible limits  
        02Hedazol Suspension 60ml Reg# 046146Metronidazole 200mg/5ml7037M/s. Heal Pharmaceuticals (Pvt.) Ltd., Peshawar.-do-
        03Vometol Suspension 120ml Reg# 094719Domperidone 5mg/5ml1347M/s. Roryan Pharmceutical Industries (Pvt.) Ltd., Peshawar.-do-
        04Tritadin Syrup 60ml Reg# 096413Loratadine 1mg/ml005M/s. Trillium Pharmaceuticals (Pvt.) Ltd., Faisalabad.-do-
        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 9255969, 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: Drug Product; Suspected Falsified Rabies Vacine

          Asad Ullah Recall Alerts
          Download

          Rapid Alert

          DRAP Alert NoNo I/S/09-24-37
          Action Date27th September 2024
          Target Audience·         Regulatory Field Force.
          ·         Healthcare Professionals – Physicians, Pharmacists, and Nurses.
          ·         Hospitals, Clinics, Pharmacies and other Healthcare Institutions
          ·         General Public.
          Problem StatementDRAP has received information about the presence of a suspected rabies vaccine in the supply chain. The product is not registered by DRAP and may be a falsified product.
          Product NameBatch/Lot No.Stated ManufacturerMfg. dateExp. date
          Rabies Vaccine, Human IP
          (SURE RAB)  
          (unregistered)          		RO10821M/s Bio-Med Private Limited,
          C-96, SITE No. 1, B.S. Rd. Indi, AREA, Ghaziabad
          (U.P.) – 201009,INDIA.          		10-202310-2026
          Threat to Public HealthRabies vaccine is used for the prevention of rabies in children and adults resulting from dog bite. Falsified rabies vaccines pose a significant threat to public health as the safety and efficacy of such products cannot be established therefore failing to provide adequate immunity, leaving individuals vulnerable to rabies infection
          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.

          Recall Alert: Drug Products; Recall of 11 Substandard Batches from the Market

          Asad Ullah Recall Alerts

          Recall Alert

          Download

          DRAP Alert NoNo I/S/09-24-36
          Action Date26th 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 has 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 are tabulated below          :-

          Therapeutic Good(s) Affected: –

          Human Use Products

          S#Product NameCompositionBatch No.Manufactured byTest Results
          01Painsa 75mg/3ml Injection
          Reg. No. 077269          		Diclofenac SodiumPA415M/s. Wimits Pharmaceuticals (Pvt.) Ltd., Lahore.Substandard
          02Metroin Infusion 100ml  

          Reg.No 071279          		Metronidazole 500mg/100mlMT24-058, MT24-060, MT24-061, MT24-062, MT24-063M/s. Saturn Pharmaceuticals (Pvt.) Ltd., Lahore. Substandard

          Veterinary Use Products

          Sr.Product NameCompositionBatch No.
          Manufactured by          		Test Results
          03Oxytocin Injection

          Reg.No 019928          		Oxytocin
          10 I.U/ml          		V6-143M/s. ISIS Pharmaceutical & Chemical Works, Karachi.Substandard
          04Selmec Injection 50ml

          Reg.No. 071087          		Ivermectin 20mg/mlSN-113M/s. Selmore Pharmaceuticals (Pvt.) Ltd., Lahore.Substandard
          05Rasomycin-10 Injection

          Reg.No. 003791          		Oxytetracyclin 100mg/mlVJ. 1340M/s. Star Laboratories (Pvt.) Ltd., Lahore.Adulterated
          06Rasomycin LA 20% Injection

          Reg.No. 003791          		Oxytetracyclin 200mg/mlVG. 1626M/s. Star Laboratories (Pvt.) Ltd., Lahore.Adulterated
          07Rasomycin-5 Injection

          Reg.No 003791          		Oxytetracyclin 50mg/mlVK. 1467M/s. Star Laboratories (Pvt.) Ltd., Lahore.Adulterated
          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 9255969, 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: Crackdown Against Spurious/falsified Drug Products

            Asad Ullah Recall Alerts
            Download

            Rapid Alert

            DRAP Alert NoNo I/S/09-24-35
            Action Date24th 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 identified products and their batch details are as under:
            S#Product NameCompositionBatch No.Manufactured by
            (as per label)            		Test Results
            01Solveron 10mg Tablets  Dydrogesterone 10mgSVN-001M/s. Solvay, Plot# 32, Sector 2, Highway Petaro Road, Jamshoro.Spurious
            02Carenol Syrup 450ml  Ammonium chloride 125mg/5ml, Sodium Citrate 55mg/5ml, Chlorphenramine Maleate 2.5mg/5mlCL-012M/s. Well Care Pharmaceuticals, A/7 P.S.I.E. Sargodha.Spurious and Misbranded
            03Procain Penicillin Fort 4000000 I.U. Injection  Procaine Penicillin 3000000 I.U., Benzyl Penicillin 1000000 I.U140475M/s. Yanzhou Xier Kangtai Pharm. Co. Ltd., China. Sole agent: United International, 301 Madian Center, Plot No. MR-1/122, 3rd Floor, Kutchi Gali No. 2, Marriot Road, Karachi.Spurious
            04Simgesic TabletTramadol HCl 37.5mg, Paracetamol 325mgB1985M/s. Siam Pharmaceutical, Plot No. 217, Industrial Triangle, Kahuta Road, Islamabad.Spurious and Misbranded
            05Meronem 500mg InjectionMeropenem 500mg4B23D121ACS Dobfar S.p.A Viale Addetta 4/12, Tribiano, Milan Italy. Packed and Marketed by: Pfizer Pakistan Limited Karachi.Spurious and Substandard
            06Meronem 1g InjectionMeropenem 1gm4A23A31ACS Dobfar S.p.A Viale Addetta 4/12, Tribiano, Milan Italy. Packed and Marketed by: Pfizer Pakistan Limited Karachi.Spurious and Substandard
            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 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.