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Recall Alert: Recall of 6 Batches of Neutrozole Infusion Manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore

Muhammad Ayub Naveed Recall Alerts, Uncategorized

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DRAP Alert NoNo I/S/11-24-51
Action Date29th November, 2024.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
– General Public
Problem / Issue The Provincial Inspector of Drugs, Punjab collected the samples of Neutrozole Infusion from various districts of Punjab and sent for test / analysis. The Drugs Testing Laboratory, Multan has declared various batches the said product, manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore, as a Substandard product. The details of the case are as under:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Neutrozole Infusion 100ml
 
Reg. No. 046878  		Metronidazole (500mg/100ml)Batch No. MZ023,
MZ028,
MZ010,
MZ007,
MZ006,
MZ003		M/s. Neutro Pharma (Pvt.) Ltd., 9.5 Km, Sheikhupura Road, Lahore-Pakistan.
Risk Statement:Administration of products containing bacterial endotoxins through IV infusion may lead to complications, such venous thromboembolism, septic shock etc. which may have fatal consequences.
Action Initiated-The manufacturer has been directed to immediately recall the defective batch of product from the market. The field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of the presence and removal of the mentioned batches from the market
-The regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

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

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

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

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

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

    Rapid Alert: Crackdown Against Falsified/Illegal Products

    Muhammad Ayub Naveed Product Recalls
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    Rapid Alert

    DRAP Alert NoNo I/S/11-24-45
    Action Date28th November, 2024
    Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
    ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
    ·        General Public
    Problem StatementDirectorate of Drugs Control (DDC) Punjab and Secretary PQCB Quetta have informed DRAP that samples of various products have been identified as spurious (falsified). Details of test reports are as under:

    S#Product NameCompositionBatch No.Manufactured by
    (as per label claim)    		Lab Test Results
    1
    Titan-1000 Injection

    Reg# 021743    		CeIftriaxone as Ceftriaxone Sodium 1000 mg/vial 22044Purported to be manufactured by Macter International Limited (as per label claim) F-216, S.I.T.E Karachi“Spurious” and “Substandard” with regards to Assay and Sterility test,
    Dyrone Film Coated Tablet

    Reg# 198069    		Dydrogesterone DR-121Purported to be manufactured by Solvay (as per label claim), Plot # 32, Sector,2 Highway Petaro Road Jamshoro SindhSpurious
    Solverone 10 mg Film Coated Tablet

    Reg# 068898    		DydrogesteroneSVN-001Purported to be manufactured by Solvay (Fictitious firm), Plot # 32, Sector,2 Highway Petaro Road Jamshoro SindhSpurious
    Dydowen 10mg Film Coated Tablet

    Reg# 101507    		Dydrogesterone736Purported to be manufactured by Weather Folds Pharmaceuticals, Hattar, Pakistan. Manufactured For: Wenovo Pharmaceuticals TaxilaSpurious
    DYDRO-FEM 10 mg Film CoatedTablet

    Reg# 555199    		DydrogesteroneDFD10/008
    DFD10/009    		Purported to be manufactured by
    Torrent Pharmaceutical, (as per label claim) G-19, Hawkesbay Road SITE, Karachi.    		Spurious
    M.CEF 30 mL Powder For Oral Suspension

    Reg# 0432189    		Cefixime as Trihydrate 100 mg/5mLD00018Purported to be manufactured by
    Dalton Laboratories PVT LTD. (as per label claim) Plot # G-149, Phase L-II Super Highway Road,
    S.I.T.E. LI Karachi    		Spurious
    Iodex Ointment

    Reg# 000394    		Iodine + MethylsalicylateHIAACPurported to be manufactured by GSK Pakistan KarachiCounterfeit
    (Falsified)
    Risk Statement:The impact of the use of falsified / Substandard products may lead to sub-optimal therapeutic effects whereas the use of a spurious product will lead to therapy failure or other associated problems.
    Action InitiatedThe field force under the administrative control of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for the detection of the presence and removal of the mentioned batches from the market.
    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 on 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.

    Recall Alert: Recall of Substandard Flagynase Suspension (Reg. No. 087528) Batch No. 0362 Manufactured by M/s Aries Pharmaceuticals (Pvt.) Ltd, Peshawar

    Muhammad Ayub Naveed Recall Alerts

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    DRAP Alert NoNo I/S/11-24-49
    Action Date20th November, 2024.
    Target Audience– National Regulatory Field Force.
    – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
    – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
    – General Public
    Problem / Issue The Federal Inspector of Drugs, Peshawar collected the samples of Flagynase Suspension and sent for test / analysis. The Central Drugs Laboratory, Karachi has declared batch No. 0362 of the said product, manufactured by M/s Aries Pharmaceuticals (Pvt.) Ltd, Peshawar, as a Substandard product.

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by
    Flagynase suspension
     
    Reg. No. 087528    		Metronidazole (200mg/5ml)Batch no. 0362
    Mfg date: 10/23
    Expiry date:
    10/25    		M/s. Aries Pharmaceuticals (Pvt.) Ltd., 1-W, Industrial Estate, Hayatabad, Peshawar. 
    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 regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

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

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

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

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

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

      Recall Alert: Recall of Nabaxo 10mg Film Coated Tablet Manufactured By M/s. Wenovo Pharmaceuticals, Taxila

      Asad Ullah Recall Alerts

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      DRAP Alert NoNo I/S/11-24-48
      Action Date15th 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 Senior Drug Inspector Islamabad has informed DRAP that batch number 263 of product namely Nabaxo 10mg film coated tablet has been declared as out of specifications by Drug Testing Laboratory Rawalpindi. Details of test reports are as under:

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by
      Nabaxo 10mg film coated tablet
       (Reg. No. 087751)      		RivaroxabanBatch No.263M/s. Wenovo Pharmaceuticals, Plot No. 31, 32, Punjab Small Industrial Estate, Taxila.
      Risk Statement:Nabaxo tablet contains Rivaroxaban is an anticoagulant medication used to treat and prevent blood clots. Rivaroxaban is used to treat deep vein thrombosis (blood clot, usually in the leg) and pulmonary embolism (blood clot in the lung) in adults. Substandard Rivaroxaban may lead to therapy failure in patients..
      Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

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

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

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

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

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

        Rapid Alert: Crackdown Against Falsified/Illegal Products

        Asad Ullah Recall Alerts
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        Rapid Alert

        DRAP Alert NoNo I/S/11-24-44
        Action Date08th November, 2024
        Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
        ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
        ·        General Public
        Problem StatementThe Directorate of Drugs Control (DDC) Punjab has identified the following falsified products in the market. The samples of these products were also analyzed by provincial Drug Testing Laboratories in Punjab. The details of the identified products are as under:

        S#Product NameCompositionBatch No.Manufactured by
        (as per label claim)        		Lab Test Results
        1Ativan 2mg Tablets

        Reg# 000084         		Lorazepam  17C7019Purported to be manufactured by Pfizer Pakistan Ltd, Karachi PakistanSpurious
        2Klozen 5 mL Eye Drops

        Reg# 040124        		Tobramycin 0.3%, Dexamethasone 0.1%134Purported to be manufactured by Zinta Pharmaceutical Industry, Hayatabad, PeshawarSpurious
        3S-Kyne 10mg Tablets

        Reg# Nil        		Dydrogesterone566Purported to be manufactured by Weather Folds pharmaceuticals, HattarSpurious & Misbranded
        4Efaston 10mg Tablets

        Reg#  31067        		Dydrogesterone064835Purported to be Manufactured by Lahore Chemical & Pharmaceutical Works (Pvt) Ltd. LahoreSpurious
        5Dydowen 10mg Tablets

        Reg# 101507         		Dydrogesterone462Purported to be Manufactured by Weather Folds Pharmaceuticals, HattarSpurious
        6Phenobar 30mg Tablets

        Reg# 018862        		PhenobarbitoneQA030Purported to be Manufactured by Star Laboratories (Pvt) Ltd (Human Healthcare Division) 23-KM Multan Road LahoreSpurious
        7Duphaston 10mg Tablets

        Reg# 006654        		Dydrogesterone230672Purported to be Manufactured by Highnoon Laboratories Ltd. Marketed by Abbot Laboratories (Pakistan) Ltd, LahoreSpurious
        Risk Statement:The impact of the use of falsified / Substandard products may lead to sub-optimal therapeutic effects whereas the use of a spurious product will lead to therapy failure or other associated problems.
        Action InitiatedThe field force under the administrative control of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for the detection of the presence and removal of the mentioned batches from the market.
        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 on 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.

        Rapid Alert: Recall of 04 Batches of Drug Products from Market

        Asad Ullah Recall Alerts
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        Rapid Alert

        DRAP Alert NoNo I/S/11-24-45
        Action Date08th November, 2024
        Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
        ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
        ·         Veterinary Healthcare Professionals
        ·  General Public
        Problem StatementDirectorate of Drugs Control (DDC) Punjab has informed DRAP that samples following products have been analyzed by the provincial DTLs in Punjab and have been declared as substandard due to reasons mentioned below. The detail of affected products is as under:

        S#Product NameCompositionBatch No.Manufactured byTest Results  
        01Nida Infusion 100ml   Reg. No. 079630Metronidazole 500mg/100ml  23E317GMP Pharmaceuticals, 28-Km Sheikhupura Road,  Lahore.Substandard due to visible particles and Bacterial Endotoxin.
        02Metroin Infusion 100ml   Reg. No. 071279Metronidazole 500mg/100ml  MT24-055Saturn Pharmaceuticals, 23-Km, thokar Raiwind Road, LahoreSubstandard due to presence of visible particles.
        03Tylosan 20 Injection 100ml   Reg. No. 027416 (For vet use only)Tylosin base 200mg/ml  TS-259Sanna Laboratories, 1019-B, P.I.S.E., Sargodha road, Faisalabad.Substandard due to presence of visible particles.
        04Melacam-10 injection 50ml   Reg. No. 063542 (For vet use only)Meloxicam 10mg/ml  23U-03Medi-vet (Pvt) Ltd., 17-Km Sheikhupura road, LahoreSubstandard on the basis of visible particles and extractable volume.
        Threat to Public HealthAdministration of products containing visible solid particles and/or bacterial endotoxins through IV infusion may lead to complications, such venous thromboembolism, septic shock etc.  which may have fatal consequences.
        Action InitiatedThe manufacturing companies of these products have been directed to immediately recall the affected batches of their products from the market. The Regulatory Field Force of DRAP and Provincial Drug Control Administrations have been directed to conduct market surveys for monitoring the recall process to ensure effective removal of defective batches from the market.

        All Pharmacists and Chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should have increased surveillance in the market to ensure the effective recall of defective products(s).
        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.

        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

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

        Therapeutic Good(s) Affected: –

        Product NamesCompositionBatch DetailsManufactured by
        Hi-Z syrup

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

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

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

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

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

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

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

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

          Asad Ullah Recall Alerts
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          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.

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          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

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            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.