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Recall Alert: PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

Ahsan Hafiz Recall Alerts

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DRAP Alert NoNo I/S/06-25-50
Action Date23rd June, 2025.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue The Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

Therapeutic Goods (s) Affected: –

Product NamesCompositionBatch DetailsManufactured byTest Results
Medistil Injection

 
Reg. No. 064758		Sterile Water for Injection……5ml25L608M/s. Medisave Pharmaceuticals,
578-579, Sundar Industrial Estate, Lahore. 		‘Substandard’ on the basis of Bacterial Endotoxin Test.
Kanadex-N Cream

 
Reg. No. 012475		Each gram contains:
Dexamethasone-21 phosphate as disodium salt…….1mg
Neomycin as sulphate…3500 i.u.		F7-27M/s ISIS Pharmaceuticals & Chemical Works,
25/1-3, Sector 12-C, North Karachi Industrial Area, Karachi.  		‘Substandard’ on the basis of Assay of Dexamethasone phosphate.
Bytec Tablet 10mg

 
Reg. No. 036183		Each Film coated tablet contains:
Cetirzine dihydrochloride…..10mg		E090M/s Batala Pharmaceuticals.,
23/B Small Industrial Estate #2, Gujranwala. 		‘Substandard’ on the basis of Impurities test.
Sterile Water for Injection 5ml


Reg. No. 071329		Sterile Water for Injection….5ml25WF01M/s Friends Pharma (Pvt) Ltd.,
 31-Km, Ferozpur Road, Lahore.		‘Substandard’ with regards to visible particulates in injection.
Cetfin 10mg Tablet

Reg. No. 091843		Each film coated tablet contains:
Cetirizine dihydrochloride ..…..10mg		CT67M/s. Effort Pharmaceuticals (Pvt.) Ltd,
28-Km, Ferozpur Road, Lahore. 		‘Substandard’ on the basis of Test for impurities (Organic impurities).
Kanabax Cream 15g

Reg. No. 070880		Each gram contains:
Dexamethasone….1mg
Neomycin Sulphate….3.5mg		KNX-270M/s. Baxter Pharmaceuticals,
A-1/A, Phase 1, S.I.T.E., Super Highway, Karachi.  		‘Misbranded’ with regards to Labeling as per Section 3(s)(iv), ‘Adulterated’ with regards to Section 3(a)(iv) of Drugs Act, 1976, and ‘Substandard’ on the basis of Assay of Neomycin and Dexamethasone Phosphate.
Surgitex Latex Surgical Gloves (powdered)

Reg. No. MDIR-0001236		Surgitex Latex Surgical Gloves Size 7.0 Powdered Sterile20241001Manufactured by:
Suzhou Colour-way New Material Co., Ltd, 20 Anmin Road, Huangdai Town, Xiangcheng District 215152, Suzhou, China.
 
Marketed by:
M/s Al-Hamd Enterprises FL-11/1/1, Block-6, Gulshan-e Iqbal, Karachi. 		‘Substandard’ with regards to Sterility Test.
Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has 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 Substandard “Famobex Suspension” Batch No. 5330, Manufactured by M/s Cibex (Pvt.) Ltd, Karachi.

    Ahsan Hafiz Recall Alerts

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    DRAP Alert NoNo I/S/06-25-49
    Action Date23rd June, 2025.
    Target Audience– National Regulatory Field Force.
    – Pharmacists and Chemists     in Distribution, Pharmacies and Medical Stores
    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
    – General Public
    Problem / Issue Federal Government Analyst, CDL, Karachi vide test report No. KQ-2-25-000015 has declared the sample of subject mentioned batch of the product as of ‘Substandard’ quality. Details of the CDL test report are as under:

    Therapeutic Goods (s) Affected: –

    Product NamesCompositionBatch DetailsManufactured byTest Results
    Famobex Suspension

     
    Reg. No. 027108    		Each 5ml contains:
    Famotidine.……10mg    		5330M/s Cibex (Private) Limited.,
    F-405, S.I.T.E, Karachi.    		‘Substandard’ on the basis of Assay test.
    Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
    Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has 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 PRODUCTS CONTAINING HYDROXYPROGESTERONE CAPROATE

      Ahsan Hafiz Recall Alerts

      Recall Alert

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      DRAP Alert NoNo I/S/06-25-48
      Action Date16th June, 2025.
      Target Audience– National Regulatory Field Force.
      – Pharmacists and Chemists       in Distribution, Pharmacies and Medical Stores
      – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
      – General Public
      Problem / Issue The Registration Board, in its 346th meeting held on 22nd April 2025, decided to ‘suspend’ registrations of products containing 17-Hydroxyprogesterone caproate, in light of the decision made by the Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) of the European Medicine Agency (EMA). The details of the marketing authorization holders of the said molecule are provided below: 

      Therapeutic Goods (s) Affected: –

      Product NamesCompositionManufactured by
      GLOBINAN INJECTION 1ML & 2ML

       
      Reg. No. 030525 & 030526      		Each ampoule contains:
      Hydroxyprogesterone caproate …..250mg      		M/s Global Pharmaceuticals (Pvt.) Ltd.,
      Plot No. 204-205, Industrial Triangle Kahuta Road, Islamabad.
      HYDROXYPROGESTERONE INJECTION

       
      Reg. No. 003746      		Each ampoule contains:
      Hydroxyprogesterone caproate …..250mg      		M/s Haji Medicines Co,
      Haji Yasin Block, Plot No. 206& 207, Industrial Triangle, Kahuta Road, Islamabad  
      NANDROSOL 250MG INJECTION

       
      Reg. No. 096479      		Each ampoule contains:
      Hydroxyprogesterone caproate …..250mg      		M/s. Pharmasol (Pvt.) Ltd.,
      Plot No. 549, Sundar Industrial Estate, Lahore.  
      HYGEST INJECTION


      Reg. No. 094205      		Each ampoule contains:
      Hydroxyprogesterone caproate …..250mg      		M/s Shaigan Pharmaceuticals (Pvt.) Ltd,
      l4 Km, Adyala Road Post Office Daghal, Rawalpindi.
      VIO-DEPOT INJECTION

      Reg. No. 013624      		Each ampoule contains:
      Hydroxyprogesterone caproate …..250mg      		M/s. Venus Pharma,
      23Km Multan Road Lahore,
      Lahore. 
      HYDROXYPROGESTERONE INJECTION

      Reg. No. 003531      		Each ampoule contains:
      Hydroxyprogesterone caproate …..250mg      		M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd.,
      L-4/1, A&8, Block 21, F.B Industrial Area, Karachi.
      Risk Statement:A review by EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC) concluded that there is a possible but unconfirmed risk of cancer in people exposed to 17-Hydroxyprogesterone Caproate in the womb. In addition, the review considered new studies which showed that the said product is not effective in preventing premature birth; there are also limited data on its effectiveness in other authorized uses.
      Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has 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 / SPURIOUS DRUGS

        Ahsan Hafiz Recall Alerts
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        Rapid Alert

        DRAP Alert NoNo  I/S/06-25-47
        Action Date13th June, 2025
        Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
        2. Healthcare Professionals
        3. Pharmacies and medical stores
        Problem StatementThe Directorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’. The details of the report are as under:

        The product identification details are as under: –

        Therapeutic Good Affected:-

        Product Batch No Manufacturer Name
        (as per label)         		Remarks
        Klaricid Tablet 500mg
         
        Each film coated contains:
        Clarithromycin……500mg        		722269XVM/s Abbott Laboratories (Pakistan) Ltd.,
        Landhi, Karachi.        		‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
        Terbisil Tablet 250mg
         
        Each tablet contains:
        Terbinafine as hydrochloride……250mg        		473M/s Saffron Pharmaceuticals (Pvt.) Ltd.,
        19 Km, Sheikhupura Road, Faisalabad.        		‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
        Carefen Suspension 450mL
         
        Each 5mL contains:
        Ibuprofen.…..100mg        		CN-37M/s Wellcare Pharmaceuticals.,
        A/7 P.S.I.E., Sargodha.        		Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
        DROPHA Tablet
         
        Each film coated tablet contains:
        Dydrogesterone…..10mg        		DRP-0005M/s Himax Pharmaceutical,
        Plot No. 445, Korangi Industrial Area, Karachi.        		‘Spurious’ as per Section 3(z-b) (i)of the Drugs Act, 1976.
        Paracetamol X-tra 1000ml
         
        Each 1000ml contains:
        Paracetamol……190g
        Brofen……..…..150g
         Caffein…………….50g
        Aspirin……….…70g
        Sorbitol……….150ml        		Mt357M/s Vibra Pharma (Pvt.) Ltd.,
        A-139- Ferozpur Road, Lahore.        		‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.

        Risk StatementFalsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
        Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. 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, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
        Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 ConsumersConsumers 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 the above mentioned 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 “Tovir 0.5mg Tablet” Batch No. 55, Manufactured by M/s Adamjee Pharmaceuticals (Pvt.) Ltd, Karachi.

        Ahsan Hafiz Recall Alerts

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        DRAP Alert NoNo I/S/06-25-46
        Action Date17th June, 2025.
        Target Audience– National Regulatory Field Force.
        – Pharmacists and Chemists         in Distribution, Pharmacies and Medical Stores
        – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
        – General Public
        Problem / Issue Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

        Therapeutic Goods (s) Affected: –

        Product NamesCompositionBatch DetailsManufactured byTest Results
        Tovir 0.5mg Tablet

         
        Reg. No. 062420        		Each tablet contains:
        Clonazepam………0.5mg        		55M/s. Adamjee Pharmaceuticals (Pvt) Ltd.,
        No. 39, Sector 15, Korangi Industrial Area, Karachi.        		‘Substandard’ on the basis of Content Uniformity test.
        Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
        Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has 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: PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

          Ahsan Hafiz Recall Alerts

          Recall Alert

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          DRAP Alert NoNo I/S/05-25-45
          Action Date2nd June, 2025.
          Target Audience– National Regulatory Field Force.
          – Pharmacists and Chemists           in Distribution, Pharmacies and Medical Stores
          – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
          – General Public
          Problem / Issue Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

          Therapeutic Goods (s) Affected: –

          Product NamesCompositionBatch DetailsManufactured byTest Results
          AMLOshine Tablet

           
          Reg. No. 062420          		Each tablet contains:
          Amlodipine as besylate…..5mg          		7840M/s. Sunshine Pharmaceuticals,
          Khan Payara, Near Saim Nala, Emanabad Gujranwala – Pakistan.          		‘Substandard’ on the basis of Impurities test.
          AMLOshine Tablet

           
          Reg. No. 062420          		Each tablet contains:
          Amlodipine as besylate…..5mg          		7623M/s. Sunshine Pharmaceuticals,
          Khan Payara, Near Saim Nala, Emanabad Gujranwala – Pakistan.            		‘Substandard’ on the basis of Impurities test.
          AMLOshine Tablet

           
          Reg. No. 062419          		Each tablet contains:
          Amlodipine as besylate…..5mg          		7361M/s. Sunshine Pharmaceuticals,
          Khan Payara, Near Saim Nala, Emanabad Gujranwala – Pakistan.            		‘Substandard’ on the basis of Impurities test.
          FLAZOL Infusion 100mL


          Reg. No. 070611          		Each 100ml vial contains:
          Metronidazole….500mg          		F250028M/s Bosch Pharmaceuticals (Pvt) Ltd.,
          209, Sector 23, Korangi Industrial Area, Karachi.          		‘Substandard’ on the basis of Bacterial Endotoxin Test.
          Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
          Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has 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: PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

            Ahsan Hafiz Recall Alerts, Uncategorized

            Recall Alert

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            DRAP Alert NoNo I/S/05-25-44
            Action Date29th May, 2025.
            Target Audience– National Regulatory Field Force.
            – Pharmacists and Chemists             in Distribution, Pharmacies and Medical Stores
            – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
            – General Public
            Problem / Issue Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

            Therapeutic Goods (s) Affected: –

            Product NamesCompositionBatch DetailsManufactured byTest Results
            Inflamac Injection

             
            Reg. No. 036110            		Each 3ml contains:
            Diclofenac sodium…..75mg            		25L-001M/s. Ipram International,
            Plot No. 26, S.S-3, National Industrial Zone, Rawat, Islamabad.            		‘Substandard’ on the basis of Visible particulates in injection.
            ZOLREST INFUSION 300mL

             
            Reg. No. 055916            		Each 300ml vial contains:
            Linezolid …….600mg            		ZL250020M/s Bosch Pharmaceuticals (Pvt.) Ltd,
            209, Sector 23, Korangi Industrial Area, Karachi.            		‘Substandard’ on the basis of Bacterial Endotoxin Test.
            LAKSOL-NS INFUSION 100mL

             
            Reg. No. 110827            		Each 100ml contains:
            Sodium chloride…0.9g            		3021489M/s Lakhani Pharma (Pvt) Ltd.,
            Sheikh Zayed Road, Rahim Yar Khan, Pakistan.            		‘Substandard’ on the basis of Bacterial Endotoxin Test. 
            QAD-FEN 90ml Syrup


            Reg. No. 121509            		Each 5ml suspension contains:
            Ibuprofen….100mg            		LS0003M/s Qadir Pharmaceuticals,
            Fateh Garh Sahuwala Road, Sialkot.            		‘Substandard’ with regards to presence of impurity (Ethylene glycol), above the permissible limit.
            BYTEC Tablet


            Reg. No. 036183            		Each film coated tablet contains:
            Cetirizine dihydrochloride ..…..10mg            		E089M/s. Batala Pharmaceuticals,
            23/B, Small Industrial Estate # 2, Gujranwala.            		‘Substandard’ with regards to Impurities test.
            Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
            Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has 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 XARELTO 15MG TABLET, BATCH NO. BXK4E11, DUE TO A LABELING ERROR ON SECONDARY PACKAGING

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              Recall Alert

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              DRAP Alert NoNo I/S/05-25-43
              Action Date20th May, 2025.
              Target Audience– National Regulatory Field Force.
              – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
              – General Public
              Problem / Issue The firm M/s Bayer Pakistan (Pvt.) Ltd., Karachi has requested for correction of a typographical error identified on the secondary packaging of Xarelto 15 mg Tablets, Batch Number BXK4E11. The error pertains to the incorrect indication of product strength on the outer label, which may lead to potential dosing errors. The details of the product are as under:

              Therapeutic Goods (s) Affected: –

              Product NamesCompositionBatch DetailsManufactured by
              Xarelto 15mg Tablet
               
              Reg. No. 072549              		Each film coated tablet contains:
              Rivaroxaban…15mg              		BXK4E11M/s Bayer Pakistan Private Limited.,
              Plot No. 23, Sector No.22, Korangi Industrial Area, Karachi.
              Risk Statement:Incorrect labeling can cause a patient to receive the wrong dosage of a medication. This may result in underdosing, where the medication is not effective, or overdosing, which can lead to harmful side effects or toxicity.
              Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of the mentioned batch of product from the market.
              – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying the mentioned batch. 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.
              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 the 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/SPURIOUS DRUGS

                Ahsan Hafiz Recall Alerts
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                Rapid Alert

                DRAP Alert NoNo  I/S/05-25-42
                Action Date19th May, 2025
                Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
                2. Healthcare Professionals
                3. Pharmacies and medical stores
                Problem StatementDirectorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’. The details of the report are as under:

                The product identification details are as under: –

                Therapeutic Good Affected:-

                Product Batch No Manufacturer Name
                (as per label)                 		Remarks
                Cefim Capsule 400mg

                Each capsule contains:
                Cefixime as trihydrate USP…400mg                		150994M/s Hilton Pharma (Pvt.) Ltd.,
                Plot No. 13-14, Sector 15, Korangi Industrial Area, Karachi.                		‘Spurious’ as per Section 3(z-b) (i)and (ii)of the Drugs Act, 1976.
                Acefyl Cough Syrup 125mL

                Each 5ml contains:
                Acefylline Piperazine……45mg
                Diphenhydramine HCL…….8mg                		ACG753M/s Nabiqasim Industries (Pvt.) Ltd.,.,
                17/24, Korangi Industrial Area, Karachi.                		‘Spurious’ as per Section 3(z-b) (i)and (ii)of the Drugs Act, 1976.
                DROPHA-10 Tablet
                 
                Each film coated tablet contains:
                Dydrogesterone…..10mg                		DRP-0012M/s Himax Pharmaceutical.,
                Plot No. 445, Korangi Industrial Area, Karachi.                		‘Spurious’ as per Section 3(z-b) (i)of the Drugs Act, 1976.
                Dydrocare 10mg Tablet

                Each film coated tablet contains:
                Dydrogesterone…..10mg                		DC-0003-YM/s Carryfor Pharmaceuticals (Pvt.) Ltd.,
                Plot No. E-81, North Western Industrial Zone, Port Qasim, Karachi.                		‘Spurious’ as per Section 3(z-b) (i)of the Drugs Act, 1976.
                Dydroplax 10mg Tablet

                Each film coated tablet contains:
                Dydrogesterone…..10mg                		DDP-0491-XM/s Carryfor Pharmaceuticals (Pvt.) Ltd.,
                Plot No. E-81, North Western Industrial Zone, Port Qasim, Karachi.                		‘Spurious’ as per Section 3(z-b) (i)of the Drugs Act, 1976.

                Risk StatementFalsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
                Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. 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, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
                Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 ConsumersConsumers 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 the above mentioned 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: CRACKDOWN AGAINST FALSIFIED/SPURIOUS DRUGS

                Ahsan Hafiz Recall Alerts
                Download

                Rapid Alert

                DRAP Alert NoNo  I/S/05-25-41
                Action Date13th May, 2025
                Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
                2. Healthcare Professionals
                3. Pharmacies and medical stores
                Problem StatementDirectorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’. The details of the report are as under:

                The product identification details are as under: –

                Therapeutic Good Affected:-

                Product Batch No Manufacturer Name
                (as per label)                 		Remarks
                Duphaston Tablet

                Each film coated tablet contains:
                Dydrogesterone…10mg                		241476M/s Highnoon Laboratories Ltd.,
                17.5 Km, Multan Road, Lahore.                		‘Spurious’ as per Section 3(z-b) (i)and (ii)of the Drugs Act, 1976.
                Calamox Tablet
                 
                Each film coated tablet contains:
                Amoxicillin Trihydrate eq. to Amoxicillin….875mg
                Clavulanate potassium eq. to Clavulanic acid…125mg                		C240712M/s Bosch Pharmaceuticals (Pvt.) Ltd.,
                221-223, Sector 23, Korangi Industrial Area, Karachi.                		‘Spurious’ as per Section 3(z-b) (i)and (ii)of the Drugs Act, 1976.
                Zamclo Tablet
                 
                Each enteric coated tablet contains:
                Diclofenac sodium…..50mg                		ZC-0023M/s Zamko Pharmaceuticals (Pvt) Ltd.,
                641-A, Sundar Industrial Estate, Lahore.                		‘Spurious’ as per Section 3(z-b) (ii)of the Drugs Act, 1976.

                Risk StatementFalsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
                Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. 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, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
                Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 ConsumersConsumers 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 the above mentioned 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.