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Product Recalls

Rapid Alert: PRESENCE OF FALSIFIED INJECTION RHOPHYLAC 300MCG, HUMAN ANTI-D IMMUNOGLOBULIN PURPORTEDLY MANUFACTURED BY M/S. CSL BEHRING AG, SWITZERLAND

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Rapid Alert

DRAP Alert NoNo  I/S/04-25-38
Action Date30th April, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDirectorate of Drugs Control Punjab (DDCP), vide Alert No. 169/2025, has notified DRAP regarding the presence of falsified Rhophylac 300mcg Injection in the market across Pakistan. Details of the identified product are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch NoPurported ManufacturerRemarks
Injection Rhophylac 300, Human Anti-D ImmunoglobulinP100669751M/s CSL Behring Switzerland, Wankdorfstrasse 10, CH-3000 Bern 22,Switzerland.‘Spurious’ as per Drugs Act 1976, section 3(z-b) (ii) and ‘Substandard’ on the basis of sterility test.

Risk StatementThe 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 conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified products. 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: SUBSTANDARD PRODUCTS DECLARED BY DRUG TESTING LABORATORIES.

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Recall Alert

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DRAP Alert NoNo I/S/04-25-37
Action Date22nd April, 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
Omsana-AM Tablet

 
Reg. No. 058557		Each film coated tablet contains:
Amlodipine (as besylate).…5mg
Olmesartan Medoxomil….20mg		155367M/s Hilton Pharma (Pvt) Ltd,
Plot No. 13-14, Sector-15, Korangi Industrial Area, Karachi.		‘Substandard’ on the basis of Test for Impurities (Organic impurities).
BYTEC Tablet

 
Reg. No. 036183		Each film coated tablet contains:
Cetirizine dihydrochloride.…10mg		E605M/s. Batala Pharmaceuticals,
23/B, Small Industrial Estate # 2, Gujranwala.		‘Adulterated’ as defined under clause (iv) of sub-section (a) of section 3 of Drugs Act, 1976.
Myteka Sachet

 
Reg. No. 039695		Each sachet contains:
Montelukast sodium eq. to Montelukast…..4mg		155384M/s Hilton Pharma (Pvt) Ltd,
Plot No. 13-14, Sector-15, Korangi Industrial Area, Karachi.		‘Substandard’ on the basis of Assay Test & Test for Impurities (Organic impurities). 
Isanex 1g Injection


Reg. No. 024657		Each vial contains:
Ceftriaxone sodium eq. to ceftriaxone…1g		IA-703M/s Humayun International Pharma (Pvt) Ltd.,
20-Km, Satiana Road, Faisalabad.  		‘Substandard’ on the basis of Sterility test & Bacterial Endotoxin Test
Medi-Lox Tablet

Reg. No.  056133		Each film coated tablet contains:
Ciprofloxacin as HCl….250mg		425M/s Medicon Pharmaceutical Industries (Pvt) Ltd.,
B-1/11, Industrial Estate, Hyatabad, Peshawar.		‘Substandard’ on the basis ofDissolution 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.

    Rapid Alert: CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUGS

    Ahsan Hafiz Recall Alerts
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    Rapid Alert

    DRAP Alert NoNo  I/S/04-25-36
    Action Date15th April, 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
    GABICA CAPSULE

    Each capsule contains:
    Pregabalin……300mg    		399C27M/s Getz Pharma (Pvt) Ltd.,
    29-30/27 , Korangi Industrial Area, Karachi.    		‘Substandard’ with regards to Assay and Dissolution, ‘Spurious’ as per Section 3(z-b) (ii)and ‘Adulterated’ as per Section 3(a)(v) of 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: SUBSTANDARD PRODUCTS DECLARED BY PROVINCIAL DRUG TESTING LABORATORIES.

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    Recall Alert

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    DRAP Alert NoNo I/S/04-25-35
    Action Date07th April, 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
    Amekoran Injection

     
    Reg. No. 053627    		Each 2mL contains:
    Amikacin (as Sulphate).…250mg    		BK-019M/s Ameer Pharma (Pvt) Ltd,
    23-Km, Sheikhupura Road, Lahore.    		‘Substandard’ on the basis of visible particulates.
    Ortizin Tablet

     
    Reg. No. 025405    		Each film coated tablet contains:
    Cetirizine dihydrochloride.…10mg    		24I268M/s. Obsons Pharmaceuticals,
    209-S, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore.    		‘Substandard’ with regards to impurities.
    AQUA-P Injection

     
    Reg. No. 034290    		Sterile water for Injection 5mlP-669M/s. IPRAM International,
    Plot No. 26, St # S.S-3, National Industrial Zone,  Rawat.    		‘Substandard’ on the basis of visible particulate matter. 
    Injection Dorcip 100ml


    Reg. No. 046086    		Ciprofloxacin as lactate….2mg/mlDC-121M/s. Trigon Pharmaceuticals (Pvt) Ltd. 8-Km, Thokar Raiwind Road, Lahore.  ‘Substandard’ with regards to visible particulates in injection and Sterility Test.
    Meclomine Tablet 500mcg

    Reg. No.  042601    		Each film coated tablet contains:
    Mecobalamine…500mcg    		8482M/s Alfalah Pharma (PVT) Ltd.,
    12-Km, Sheikhupura Road, Lahore.    		‘Adulterated’ as per section 3(a)(iv) of Drugs Act, 1976.
    Meclomine Tablet 500mcg


    Reg. No. 042601    		Each film coated tablet contains:
    Mecobalamine…500mcg    		8440M/s Alfalah Pharma (PVT) Ltd.,
    12-Km, Sheikhupura Road, Lahore.    		‘Substandard’ on the basis ofPhysical Description & Assay Testand ‘Adulterated’ as per section 3(a)(iv) of Drugs Act, 1976.
    Injection Neocobal

    Reg. No. 042601    		Mecobalamine 0.5mg/mlS-2455M/s Pulse Pharmaceuticals (Pvt.) Ltd.,
    Sua Aasil, Raiwind Road, Lahore.    		‘Substandard’ on the basis ofAssay Testand ‘Adulterated’ as per Drugs Act, 1976.
    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: Substandard Products Declared by Provincial Drug Testing Laboratories.

      Ahsan Hafiz Recall Alerts

      Recall Alert

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      DRAP Alert NoNo I/S/03-25-34
      Action Date27th March, 2025.
      Target Audience– National Regulatory Field Force of DRAP and Provincial Drug Control Departments
      – Healthcare Professionals – Veterinarians
      – Farmers/consumers
      Problem / Issue Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been reported as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by

       
      Zaktyl-20 Injection

      For veterinary use only
       
      Reg. No. 052317

      		Tylosin Tartrate 230mg/100mlZKA077M/s Zakfas Pharmaceuticals (Pvt) Ltd.
      12-Km, Bosan Road, Multan.
      Risk Statement:The use of substandard veterinary product can result in therapy failure, increasing the risk of complications and potentially contribute to the development of drug resistance
      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 the product from the market.
      Advice for VeterinariansDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.

      -Please click here for further information on problem reporting to DRAP.
      Advice for Farmers/ ConsumersFarmers/consumers should not use this product. They shall contact their veterinarians or healthcare provider(s) if the animal experienced any problem that may be related to using this product.

        Recall Alert: Substandard Products Declared by Provincial Drug Testing Laboratories

        Ahsan Hafiz Recall Alerts

        Recall Alert

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        DRAP Alert NoNo I/S/03-25-33
        Action Date27th March, 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 by

         
        Tablet AMLOShine 5mg

         
        Reg. No. 062420

        		Each tablet contains:
        Amlodipine as besylate…5mg        		7974M/s Sunshine Pharmaceuticals,
        Khan payara, near Saim Nala, Emanabad Road, Emanabad, Gujranwala
        Powder for Inj. Tyclan

         
        Reg. No. 087923
        		Each vial contains:
        Teicoplanin B.P….400mg        		TL-011M/s. MTI Medical (Pvt) Ltd,
        586-587, Sundar Industrial Estate, Lahore.
        Injection Linco-HCL

         
        Reg. No. 023729
        		Each 2ml ampoule contains:
        Lincomycin as HCl….600mg        		LN-042M/s. Trigon Pharmaceuticals (Pvt) Ltd.
        8-Km, Thokar Raiwind Road, Lahore.
        Safemed Infusion

         
        Reg. No. 045824        		Each 100ml vial contains:
        Metronidazole…500mg        		SJU-1724M/s. Ahad International Pharmaceuticals Ltd.
        13-Km, Gomal University, Multan Road Dera Ismail Khan. 
        Ketamine hydrochloride Injection

         
        Reg. No.  NA        		Each ml contains:
        Ketamine hydrochloride eq. to ketamine …50mg        		GN1359M/s KWALITY Pharmaceuticals Ltd.,
        Nag kalan, Majitha Road, Amristsar 143 601 (India).
        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.

          Rapid Alert: CONTAMINATED PROPYLENE GLYCOL (BATCH # YFO1210911) PURPOTEDLY MANUFACTURED BY M/S. DONGYING HI-TECH SPRING CHEMICAL INDUSTRY CO LTD, CHINA.

          Muhammad Ayub Naveed Recall Alerts
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          Rapid Alert

          DRAP Alert NoNo  I/S/03-25-32
          Action Date15th March, 2025
          Target Audience1. Regulatory Field Force.
          2. Therapeutic Goods industry
          3. Manufactures of Oral liquid preparations
          4. Healthcare professionals
          Problem StatementDirectorate Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan vide test/analysis report No. 141002343, wherein the sample of Propylene Glycol (Raw Material) has been declared ‘Substandard’. The falsified excipient was detected in the unregulated supply chain marketed through Facebook page and tested by Drug Testing Laboratory (DTL), Lahore. The contaminated propylene glycol batch (YFO1210911) was purported to be manufactured by Dongying Hi-Tech Spring Chemical Industry China. The results of test have revealed that the level of EG in the batch was 91.4%, far exceeding the accepted criteria of 0.1%. Details of test/analysis report are tabulated as under:

          The product identification details are as under: –

          Therapeutic Good Affected:-

          ProductBatch No*Mfg DateExp. DateManufacturer Name
          (as per label)          		Remarks
          Propylene Glycol
          (Raw material)          		YFO121091101-202401-2026M/s. Dongying Hi-Tech Spring Chemical Industry Co Ltd, ChinaThe sample is declared substandard
          due to conatmination of Ethylene Glycol.
          (Note: Earlier in December 2024, DRAP issued a Rapid Alert for the same batch of falsified Propylene Glycol (Raw material) tested by CDL Karachi in compliance to advisory issued by DRAP vide No. 03-41/2023-QC dated 01-12-2023. In this regard, Hi Tech Spring China has confirmed that the said batch is not their product. The firm has provided the original product label, and a comparison between the original and falsified product labels is presented below)

          Risk StatementDi-Ethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
          Action InitiatedThe Regulatory Field Force has directed to take increase surveillance for identification of above mentioned contaminated batch of Propylene Glycol in the market and is investigating the entire supply chain of this batch. The Regulatory Field Force has also been instructed to seize all oral preparations manufactured using the same batch of propylene glycol if found in the market.
          Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
           
          1.      Recall Products: If any batch was manufactured using the same lot of Propylene Glycol that has been identified as contaminated, all finished products from local and export markets should be recalled.
          2.      Hold Other Batches: All finished products manufactured from the same lot of propylene glycol should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain.
          3.      Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.
          4.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.
          5.      Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.

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

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

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

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

          Rapid Alert: CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUGS

          Muhammad Ayub Naveed Recall Alerts
          Download

          Rapid Alert

          DRAP Alert NoNo  I/S/03-25-31
          Action Date13th March, 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 samples of below mentioned products have been declared ‘Spurious’. The details of the report are as under:

          The product identification details are as under: –

          Therapeutic Good Affected:-

          ProductBatch No*Mfg DateExp. DateManufacturer Name
          (as per label)          		Remarks
          PENIVET-5 Injection
          Each vial contains:
          Benzyl Penicillin……500,000IU
          Procaine Penicillin….1500,000IU
          Streptomycin Sulphate…5g 
           
          (For Veterinary use only)
           
          Reg. No. 034290          		VK-1496Purported to be manufactured by
          M/s. Star Laboratories (Pvt) Ltd. 
          (Animal Health Care Division) 23-Km, Multan Road, Lahore-Pakistan          		Spurious with regardsto Section 3(zb)(i) & (ii) of Drugs Act 1976 and  ‘Substandard’ on the basis of Sterility test.

          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 products. 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

          Muhammad Ayub Naveed Recall Alerts
          Download

          Rapid Alert

          DRAP Alert NoNo  I/S/03-25-30
          Action Date13th March, 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 detail of report is as under

          The product identification details are as under: –

          Therapeutic Good Affected:-

          ProductBatch No*Mfg DateExp. DateManufacturer Name
          (as per label)          		Remarks
          KLOZEN Eye Drops 5ml
          (Tobramycin….0.3% & Dexamethasone….0.1%)          		138M/s Zinta Pharmaceutical Industry,
          168 – Industrial Estate Hyatabad, Peshawar.          		‘Spurious’ with regards to Section 3(zb)(i) and ‘Adulterated’ with regards to Section 3(a)(iv) of 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 products. 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.