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Recall Alert: Drug Product; Moxtrex 400mg Tablets (Batch # 850) by M/s Gillman Pharmaceuticals, Hattar, Khyber Pakhtunkhwa

Asad Ullah Product Recalls, Recall Alerts

Recall Alert

DRAP Alert NoNoII/S/10-22-32
Action Date3rd November 2022
Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Moxtrex 400mg Tablets,
Active Ingredient(s): Moxifloxacin
Company: M/s Gillman Pharmaceuticals, Hattar.
Batch No. 850
Manufacturing Date: 06-2022
Expiry Date: 06-2024
Problem / Issue Drug Testing Laboratory (DTL) Rawalpindi has analyzed the samples of Moxtrex 400mg Tablets manufactured by M/s Gillman Pharmaceuticals, Hattar, KPK and declared the batch No. 850 as “substandard” based on the analysis report.
Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

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

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

-All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
    Moxtrex-400mg-TabDownload

    Recall Alert: Drug Product; Ceficure 400mg Capsules (Batch # C-737) by M/s Max Pharmaceuticals Islamabad

    Asad Ullah Product Recalls, Recall Alerts

    Recall Alert

    DRAP Alert NoNoII/S/10-22-30
    Action Date2nd November 2022
    Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
    2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
    3. General Public
    Product(s) Affected Ceficure 400mg Capsules,
    Active Ingredient(s): Cefixime
    Company: M/s MAX Pharmaceuticals, Islamabad.
    Batch No. C-737
    Manufacturing Date: 06-2022
    Expiry Date: 05-2024
    Problem / Issue The Drug Testing Laboratory (DTL), Rawalpindi has analyzed the sample of batch No. C-737 of Ceficure 400mg Capsule manufactured by M/s. Max Pharmaceutical, Islamabad, and declared it as “misbranded” drug product.
    Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

    -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

    -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

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

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

    -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
      Ceficure-cap-Recall-AlertDownload

      Recall Alert: Drug Product; Telsarta 40mg Tablets (Batch # 2B151) by M/s PharmEvo Pharmaceuticals Pvt Ltd. Karachi

      Asad Ullah Product Recalls, Recall Alerts

      Recall Alert

      DRAP Alert NoNoII/S/10-22-31
      Action Date2nd November 2022
      Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
      2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
      3. General Public
      Product(s) Affected Telsarta 40mg Tablets,
      Active Ingredient(s): Telmisartan
      Company: M/s PharmEvo Pharmaceuticals Pvt, Ltd. Karachi
      Batch No. 2B151
      Manufacturing Date: 02-2022
      Expiry Date: 01-2024
      Problem / Issue Drug Testing Laboratory (DTL) Rawalpindi has analyzed the samples of Telsarta 40mg Tablets manufactured by M/s PharmEvo Pharmaceuticals Pvt Ltd, Karachi and declared the batch No. 2B151 as “substandard” based on the analysis report.
      Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

      -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

      -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

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

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

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

        Minutes of 1st Meeting of Pharmacovigilance Risk Assessment Expert Committee (PRAEC) held on 12-October, 2022

        Asad Ullah Meeting Minutes, Pharmacovigilance RAE Committee ,

        1st meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) was held in the Committee Room of the Drug Regulatory Authority of Pakistan (DRAP) on the 12th of October, 2022. The minutes of meeting are attached hereunder:-

        Minutes-of-1st-meeting-of-PRAEC-24-10-2022-FinalDownload

        Suspected Falsified Alert; Drug Products; Suspected Anti-D Immunoglobulin Injection in the market

        Asad Ullah Recall Alerts, Regulatory Updates

        Rapid Alert

        DRAP Alert NoNoI/S/10-22-29
        Action Date28th October 2022
        Target Audience1. Regulatory Field Force
        2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
        3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions
        4. General Public
        Problem StatementDRAP received a complaint regarding the presence of following suspected product in the market. This product is not imported and marketed by the authorized registration holder and neither DRAP has issued import clearance for this product. National Control Laboratory for Biological has also not issued any lot release to this product.
        SrProduct NameCompositionBatch #Manufactured by (as stated on label)
        101 IMMUNORHO 300µg (1.500iu)
        (PFS; Pre-filled syringe)         		Human anti-D immunoglobulinM05W25212M/s. KEDRION BIOPHARMA.
        Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate this product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The remaining stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of suspected products.
        Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products.

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

        -Please click here for further information on problem reporting to DRAP.
        Advice for Consumers-Consumers should stop using this product and shall contact to 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 Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

        -All therapeutic goods must be obtained from the licensed pharmacies, and other authorized / licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.
        Pictures of Suspected falsified product
        immunorho-safety-alert-revisedDownload

        Regulatory Update / Advisory; Recall of Targocid 200mg powder for solution for injection/infusion or oral solution in UK

        Asad Ullah News & Updates, Recall Alerts, Regulatory Updates

        Date:   31st October, 2022

        Target Audience: –  

        • Healthcare Professionals- Physicians, Pharmacists, and Nurses.
        • General Public

        Problem or Issue: –

        Sanofi UK has initiated an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution (Batch Number 0J25D1 and Batch Number 0J25D2). Reason for recall is the out of specifications results obtained for bacterial endotoxins in the retained samples.

        However, both of these batches were not imported or marketed in Pakistan by the authorized registration holder company, hence, Pakistan’s market will not be affected by this recall operation.

        Nonetheless, DRAP has directed registration holder company to test the retaining samples of other batches which are supplied in Pakistan to ensure that problem is not extended beyond the identified two batches.  

        Advice for healthcare professional: –

        Healthcare professionals should be aware of the clinical symptoms related to the potential risk to patient health; a high temperature (fever) or low body temperature, chills and shivering, cold, clammy and pale or mottled skin, a fast heartbeat, fast breathing, severe breathlessness, severe muscle pain, feeling dizzy or faint, a change in mental state – such as confusion or disorientation, loss of consciousness, slurred speech, nausea and vomiting and/or diarrhea.

        Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.  Further information on how to report a problem to DRAP is available on this link.

        Advice for general public: –

        Since, these affected batches have not been imported or supplied in Pakistan by the marketing authorization holder, no recall is initiated for this product in Pakistan. These these batches were supplied and being recalled in the UK market only. However, if any person has carried these affected batches for their personal use they are advised not to consume it, and consult their healthcare provider immediately.

        ADVISORY-TARGOCID-final-revisedDownload

        DRAP finalizes Guidelines on the Preparation of Summary of Product Characteristics (SmPC)

        Asad Ullah Drugs, Regulatory Updates

        The Summary of Product Characteristics (SmPC) are the basic information for healthcare professionals on the use of drug products to ensure safety, efficacy and quality, and also provides a basis for preparation of the Patient Information Leaflet (PiL). SmPC describes the set of characteristics of a drug product as determined through the assessment process during registration of a drug product.

        SmPC guidelines are intended to provide supportive information for preparation of Summary of Product Characteristics (SmPC) for registration / market authorization of pharmaceutical and biological products of all types including New drug products, Generic drug products and Biosimilars.

        Rule 26 of the Drugs (Licensing, Registering & Advertising) Rules, 1976, as amended vide S.R.O 713(I)/2018 dated 8th June 2018, under 26(1) section 1.5.14 requires that in order to obtain registration/marketing authorization of drug product, a Summary of Product Characteristics (SmPC) is required to be included in the application dossier. The SmPC is part of drug registration / marketing authorization approval, and its contents can only be changed with the approval of Competent Authority. In this context, Registration Board has deliberated the contents of summary of Product Characteristics for pharmaceutical and biological drug products. This document transforms the decisions and advices of Registration Board into a guidance document for preparation of SmPC with application dossier submission in the CTD module.

        The draft guidelines were prepared three years ago and was available on the DRAP’ s website. Stakeholders have submitted their comments on the draft document and accordingly guidelines have been finalized after careful consideration of stakeholder’s comments.

        Please click to view the final document, GUIDELINES ON Preparation of Summary of Product Characteristics

        For more information on Regulatory Guidelines published by DRAP, please navigate to Publications tabs on our website.