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Year: 2022

Recall Alert: Drug Product; Human Albumin 20% 100mL (Batch/Lot # C236821P02) Manufactured By M/s. Biotest Pharma GmbH

Asad Ullah Product Recalls, Recall Alerts, Safety Info

Recall Alert

DRAP Alert NoNoI/S/10-22-25
Action Date7th October 2022
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Human Albumin 20% 100mL (Biotest),
Active Ingredient(s): Serum Albumin 20% (Human)
Company: M/s. Biotest Pharma GmbH, Germany imported by M/s Eastren Trade & Distribution Co, (Pvt) Limited, Karachi
Batch No. C236831P02
Manufacturing Date: 17-Sep-2021,
Expiry Date: 31-Aug-2024
Problem StatementDRAP has received a rapid alert from the Paul-Ehrlich Institut, Federal Institue of Vaccine and Biomedicines, Ministry of Health, Germany, with respect to the quality defect and voluntary recall of 06 batches of Human Albumin 20%, 100mL manufactured by the Botest AG, GmbH. Out of these six batches, one batch was imported in Pakistan by the authorized registration holder M/s Eastren Trade & Distribution Co, (Pvt) Limited, Karachi.
Action InitiatedThe importer has been directed to immediately recall the stock of defective batch C236831P02 from the market. Regulatory field force is directed to supervise the recall progress.

-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.
    DRAP’s Recall of Human-Albumin-GmbHDownload

    Recall Alert: Drug Product; Fentos 50mg Tablets (Batch # 599) By M/s. Hisun Pharmaceutical Industries, Gadoon-Pakistan

    Asad Ullah Recall Alerts

    Recall Alert

    DRAP Alert NoNoII/S/09-22-21
    Action Date6th October, 2022
    Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
    2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions
    3. General Public
    Product(s) Affected Fentos 50mg Tablets,
    Active Ingredient(s): Diclofenac Potassium
    Company: M/s. Hisum Pharmaceutical Insutries Gadoon, Pakistan
    Batch No. 599
    Manufacturing Date: Sep-2021,
    Expiry Date: Sep-2023
    Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Fentos 50mg Tablets (Registration No. 047810) bearing Batch No. 599, and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
    Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the 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) have also increased surveillance in the market to ensure the effective recall of defective product(s).
    Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

    -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 if they have experienced any problems that may be related to taking or using this drug product.

    All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.
      DRAP-Recall-of-Fentos-Tablet-Hisun-batch-599Download

      Recall Alert; Drug Product: Pantoloon 20mg Tablets (Batch # 5611) By M/S. Rock Pharmaceutical Laboratories (Pvt.) Ltd. Risalpur

      Asad Ullah Product Recalls, Recall Alerts, Safety Info

      Recall Alert

      DRAP Alert NoNoII/S/09-22-22
      Action Date5th October, 2022
      Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
      2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions
      3. General Public
      Product(s) Affected Pantoloon 20mg Tablets,
      Active Ingredient(s): Pantoprazole
      Company: M/s. Rock Pharmaceutical Laboratories (Pvt.) Ltd. Risalpur .
      Batch No. 5611
      Manufacturing Date: May-2022,
      Expiry Date: Mar-2024
      Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Pantoloon 20mg Tablets (Registration No. 095091) bearing Batch No. 5611, and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
      Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the 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) have also increased surveillance in the market to ensure the effective recall of defective product(s).
      Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

      -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 if they have experienced any problems that may be related to taking or using this drug product.

      All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

      Recall Alert; Drug Product: Zatranex 50mg/mL injection (Batch # 622) by M/s. Zafa Pharmaceutical Laboratories (Pvt.) Ltd., Karachi.

      Asad Ullah Product Recalls, Recall Alerts, Safety Info

      Recall Alert

      DRAP Alert NoNoI/S/09-22-23
      Action Date5th October, 2022
      Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
      2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions
      3. General Public
      Product(s) Affected Zatranex 50mg/mL Injection,
      Active Ingredient(s): Tranexamic Acid
      Company: M/s. Zafa Pharmaceutical Laboratories (Pvt.) Ltd., Karachi.
      Batch No. 622
      Manufacturing Date: April-2022,
      Expiry Date: April-2025
      Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Zatranex 50mg/ml Injection (Registration No. 014217) bearing Batch No. 622, and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
      Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the 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) have also increased surveillance in the market to ensure the effective recall of defective product(s).
      Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

      -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 if they have experienced any problems that may be related to taking or using this drug product.

      All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.
      DRAP Recall Alert Zatranex Inj (Zafa) Batch 622Download

      110th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

      Asad Ullah Enlistment Evaluation Committee

      The 110th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 3rd August, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.

      Deficiency-letter-of-110th-meeting-of-EEC-CopyDownload

      109th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

      Asad Ullah Enlistment Evaluation Committee

      The 109th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 5th July, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.

      Deficiency-letter-of-109th-meeting-of-EECDownload

      108th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

      Asad Ullah Enlistment Evaluation Committee

      The 108th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 22nd June, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.

      Deficiency-letter-of-108th-meeting-of-EECDownload

      107th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

      Asad Ullah Enlistment Evaluation Committee, Meeting Minutes, Publications

      The 107th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 23rd May, 2022. The detail of applications which required further information /clarification and documentation is attached hereunder for information by all stakeholders.

      Deficiency-letter-of-107th-meeting-of-EECDownload

      DRAP issued Guidelines on Management of High Alert Medication

      Asad Ullah Pharmacovigilance, Regulatory Updates , ,

      DRAP envisions advancement in the healthcare system of Pakistan by working at par with international standards, and best regulatory practices through effective management and regulation of therapeutic goods. The National Pharmacovigilance Centre (NPC) at DRAP issues guidelines from time to time for different activities relating to Pharmacovigilance and promotion of pharmacy services to cater to the needs of different stakeholders.

      High Alert medicines are those that have a high risk of causing injury or harm if they are misused or used in error. NPC, DRAP has issued a a Guidelines on Management of High Alert Medication to illustrate recommended practices for safe handling of those drug products that are classified as High Alert Medication (HAM). 

      The main objective for issuing this guidance document is to support healthcare professionals working at hospitals and healthcare services providing institutes for ensure safe practices for prescribing, dispensing, administration and monitoring of high alert medication (HAM) and applies to all healthcare settings and healthcare professionals involved in the handling and usage of HAM. The outlined and recommended strategies are intended to educate HCPs, prevent risks associated with HAM, implement safety checks and encourage reporting of Adverse Events /Adverse Drug Reactions. 

      This draft guideline was uploaded on the official website of DRAP dated 16th June, 2022 with request of comments submissions by the stakeholders. The National Pharmacovigilance centre, Division of Pharmacy Services has finalized the documents after careful evaluation of the comments and input received from internal and external stakeholder consultation.

      Suggestions can be forwarded via email to npc∂dra.gov.pk, copying at aqsa.hashmi∂dra.gov.pk , or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

      click to view the Guidelines on Management of High Alert Medication (Edition 01). For more information related the regulatory guidelines and guidance documents issued by the DRAP please navigate to the Publications > Guidelines tab of our website.