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Falsified Vigamox® Ophthalmic Solution – Batch VHF02A (Not from Authorized Source)

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Rapid Alert

Falsified Vigamox® Ophthalmic Solution – Batch VHF02A (Not from Authorized Source)

DRAP Alert NoNo I/S/09-25-66
Action Date17th September, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementNovartis Pharma (Pakistan) Ltd., Karachi informed DRAP that falsified Vigamox® Sterile Ophthalmic Solution bearing Batch # VHF02A is identified in the Pakistani market. The reported batch number is not imported, manufactured, or supplied by Novartis Pharma (Pakistan) Ltd., i.e. the genuine registration holder in Pakistan. The packaging falsely uses the Novartis name and branding, but it does not come from the authorized supply chain.
Please click downlaod button on top of page for Rapid Alert with pictorial guidance to identify the falsified comparsion with original product.
Risk StatementIn the case of Vigamox® (Batch No. VHF02A), such falsification may result in ineffective treatment of bacterial eye infections, potential worsening the infection, and risk of serious eye damage or vision loss. This alert applies only to Batch No. VHF02A and does not affect other batches of Vigamox® in the market supplied by the authorized registration holder. The falsified batch poses a particular risk to patients with eye infections, especially children, the elderly, and those with weakened immune systems, who may experience rapid deterioration if untreated or improperly treated.
Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned 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: Lipidem® / Lipoplus® Emulsion for Infusion (Product Stability Risk)

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Recall Alert

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Lipidem® / Lipoplus® Emulsion for Infusion (Zone IV Stability Risk for Pakistan)

DRAP Alert NoNo I/S/09-25-65
Action Date17 September, 2025.
Target Audience·         Hospitals (Public & Private): especially those with ICU, surgical, oncology, and nutrition support units.
·         Parenteral Nutrition Centre / Clinical Nutrition Teams: where lipid emulsions are routinely administered.
·         Pharmacists: particularly hospital pharmacists and those in charge of sterile/IV admixtures.
·         Physicians: especially intensivists, anesthesiologists, gastroenterologists, and pediatricians using parenteral nutrition.
·         Provincial Health Authorities & Regulatory Bodies: to ensure monitoring and enforcement at the provincial level.
·         Importer & Distributors: of Lipidem® / Lipoplus® in Pakistan.
·         Nursing Staff: involved in IV infusion preparation and administration.
Problem / Issue Stability studies conducted by the manufacturer and German regulatory authority identified droplet-like agglomerates (subvisual fat particles) in Lipidem® / Lipoplus® emulsions stored at 25°C beyond 12 months. These agglomerates, if infused without appropriate filtration, may lead to serious adverse events, including fat embolism in pulmonary capillaries. The details of the product is as under: –

Therapeutic Goods (s) Affected: –

S#Reg. #Name of Drug(s) & CompositionPackingShelf LifeImporter details
1.099492Lipoplus Emulsion for Intravenous Infusion
Each 1000 ml contains:
Medium chain triglycerides…. 100gm
Soya oil …………………… 80gm
Omega-3-acid triglycerides… ….20gm
(As per Innovator’s Specification)*		250m1 Glass Bottle02 yearsM/s B.Braun Pakistan (Pvt) Ltd, The Forum, Suite 216 Khayaban-e-Jami, Clifton Block 9, Karachi.   Godown address: Ground Floor Plot No. C-153, S-6F, Mehran Town, Karachi.
Risk Statement:In stability studies conducted in Germany, droplet-like agglomerates were detected in Lipidem® / Lipoplus® emulsions stored at 25 °C beyond 12 months. To mitigate this risk under those conditions, the German authority recommended the use of a 1.2 µm lipid infusion filter during administration.

Since Pakistan falls under Zone IV climatic conditions (hot and humid), which differ significantly from Germany (25°C), the risk of earlier onset of agglomerate formation cannot be excluded. To date, no stability information or scientific justification for Zone IV conditions has been provided by the manufacturer or Marketing Authorization Holder (MAH). Considering these factors and the higher temperature and humidity in Pakistan, the matter is classified as a Class I recall risk, as the defect may reasonably be expected to cause serious adverse health consequences if not managed appropriately.
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 returned to the supplier/company.

–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 (Class-II) – Drug Products Declared substandard by Directorate of Drugs Control Punjab (DDCP)

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    Recall Alert

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    DRAP Alert NoNo II/S/09-25-64
    Action Date15 September, 2025.
    Target Audience– National Regulatory Field Force.
    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
    – General Public
    Problem / Issue Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared as ‘Substandard’.

    Therapeutic Goods (s) Affected: –

    S#Product NameBatch No.ManufacturersRemarks
    1.Tablet Ortizin 10mg   Each film coated tablet contains: Cetirizine 2HCl ……10 mg    24L377M/s Obsons Pharmaceuticals. 209-S Industrial Estate Kot Lakhpat Lahore. (DML # 000416)DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of assay and impurities testing.
    2.Tablet Daisy 10 mg   Each film coated tablet contains:  Cetirizine 2HCl ……10 mg  25B084 & 25B085  M/s Mega Pharmaceuticals Ltd.   27 Km Raiwind Road Lahore. (DML # 000537)DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of impurities testing (Organic impurities).
    3.Tablet Ascard 75   Each enteric coated tablet contains: Acetyl Salicylic acid …. 75 mg  AR076K  M/s Atco Laboratories Limited.   B-18 S.I.T.E Karachi. (DML # 000188)DDCP Alert No. l73/2025 declared the sample as ‘substandard’ on the basis of test for related substance (Impurity C: Salicylic Acid).
    4.Tablet Bytec 10mg   Each film coated tablet contains:  Cetirizine 2HCl ……10 mg  E604, E605 & E606  M/s Batala Pharmaceuticals. 23/B Small Industrial Estate No. 2 Gujranwala. (DML # 000477)DDCP Alert No. l79/2025 declared the sample as ‘substandard’ on the basis of impurities testing.
    5.Tablet Vivin 10 mg   Each film coated tablet contains:  Cetirizine 2HCl ……10 mg315M/s Murfy Pharmaceuticals (Pvt) Ltd. 8-Km Raiwind Road Lahore. (DML # 000543)DDCP Alert No. l79/2025 declared the sample as ‘substandard’ on the basis of impurities testing.
    Risk Statement:The above-mentioned batches of tablets have been declared substandard due to failure in assay and impurities testing, including elevated levels of related substances. Use of these defective medicines may lead to reduced therapeutic effect, unpredictable side effects, and potential toxicity.
    Patients, pharmacists, and healthcare providers are advised to discontinue the affected batches immediately and report any adverse events to DRAP.
    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 returned to the supplier/company.

    –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 (Class-I) – Drug Products declared substandard by Directorate of Drugs Control Punjab (DDCP)

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      Recall Alert

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      DRAP Alert NoNo I/S/09-25-63
      Action Date15 September, 2025.
      Target Audience– National Regulatory Field Force.
      – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
      – General Public
      Problem / Issue Drug Testing Laboratories from Provinces informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      S#Product NameBatch No.ManufacturersRemarks
      1STERILE OPHTHALMIC SUSPENSION 5 ML BROMYCIN-D   Each ml contains: TOBRAMYCIN 3MG, DЕХАМЕТHASONE 1MG    6892M/s Innvotek Pharmaceuticals. Plot No.35 Industrial Estate Kahuta Triangle Islamabad. (DML # 000487)Drug Testing Laboratory, Rawalpindi declared the sample as ‘substandard’ quality on the basis of the result of Sterility test.
      2.Injection Metrorise   Each 100ml vial contains: Metronidazole USP … 500mg (0.5% w/v)  LV-2504  M/s Pak Risen Pharmaceuticals. Plot No. 3 Block B Phase-I-II Industrial Estate Hattar. (DML # 000573)  Drug Testing Laboratory, Bahawalpur declared the sample as ‘substandard’ quality on the basis of the result of Bacterial Endotoxin test.  
      3.Sterile water for injection 5ml   Each glass ampoule contains Sterile water for injection 5ml    24L608  M/s Medisave Pharmaceuticals. Plot No.578-579 Sundar Industrial Estate Lahore. (DML # 000681)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of the result of Bacterial Endotoxin test.  
      4.Sterile water for injection 5 ml   Each glass ampoule contains Sterile water for injection 5ml25WF01  M/s Friends Pharma (Pvt) Ltd. 31-Km Ferozepur Road Lahore. (DML # 000681)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of visible particulate matter.  
      5.ELPOMIDE INJ 10mg/2ml   Metoclopramide HCl BP 10mg/2ml  332  M/s Elite Pharma (Pvt) Ltd. 9.5 Km Sheikhupura Road Lahore. (DML # 000455)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of visible particulate matter.
      6.Injection Aqua-P 5ml Each glass ampoule contains Sterile water for injection 5ml P-672  M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of visible particulate matter.  
      7.Water for injection 5 ml Sterile water for injection 5ml.  130  M/s Wilshire Laboratories (Pvt) Ltd.  124/1 Industrial Estate Kot Lakhpat Lahore. (DML # 000232)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of the result of Bacterial Endotoxin test.  
      8.Sterile water for injection 10 ml   Each glass ampoule contains Sterile water for injection 10 ml  084L24  M/s Brookes Pharma (Pvt) Ltd.   Plot No. 58-59 Sector No. 15 Korangi Industrial Area Karachi. (DML # 000275)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of the result of sterility test.  
      9.Syrup Salbovent 60ml   Each 5ml contains: Salbutamol (as sulphate) …… 2mg  L25D52  M/s Synchro Pharmaceuticals.  77-Industrial Estate Kot Lakhpat Lahore. (DML # 575)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of the result of impurity (ethylene glycol) above the permissible limits.  
      10.Injection Vitamin K1   Each ml contains: Phytomenadione ……… 2 mg  H-18825  M/s Venus Pharma.  23 Km Multan Road Lahore. (DML # 000300)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of the result of sterility test.  
      11.SNDOL Suspension 60 ml   Each 5ml contains:  Paracetamol ………. 120 mg  917  M/s S.N.B Pharma (Pvt) Ltd.   Plot No. 142 Industrial Estate Hayatabad Peshawar. (DML # 000759)  DDCP Alert No. l73/2025 declared the sample as ‘substandard’ on the basis of the result of impurity (ethylene glycol) above the permissible limits.  
      12.Resgyl Suspension 60 ml   Benzoyl Metronidazole eq. to Metronidazole ……. 200mg / 5ml  4E566  M/s Rasco Pharma (Pvt) Ltd.  5.5 Km Raiwind Road Ali Razabad, Lahore. (DML # 000530)  DDCP Alert No. l73/2025 declared the sample as ‘substandard’ on the basis of the result of impurity (ethylene glycol) above the permissible limits.  
      13.Syrup Syandin 60 ml   Each 5ml contains: Loratadine ………… 5 mg  L25E57  M/s Synchro Pharmaceuticals.  77-Industrial Estate Kot Lakhpat Lahore. (DML # 575)  DDCP Alert No. l73/2025 declared the sample as ‘substandard’ on the basis of the result of impurity (ethylene glycol) above the permissible limits.  
      14.Injection Neocobal 1 ml Mecobalamin 0.5mg/ml  S-2621  M/s Pulse Pharmaceuticals (Pvt) Ltd.  Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564)  DDCP Alert No. l73/2025 declared the sample as ‘substandard’ and ‘adulterated’.  
      15.Infusion NIDA 100 ML Metronidazole 500mg/100ml  25D055  M/s GMP Pharmaceuticals. 28-Km Sheikhupura Road Lahore. (DML # 000815)  DDCP Alert No. l77/2025 declared the sample as ‘substandard’ on the basis of visible particulate matter.  
      16.Metrorise injection Metronidazole 500mg/100ml  LV-2422  M/s Pak Risen Pharmaceuticals. Plot No. 3 Block B Phase-I-II Industrial Estate Hattar. (DML # 000573)  DDCP Alert No. l77/2025 declared the sample as ‘substandard’ on the basis of Bacterial Endotoxin Test.  
      17.Infusion Revasol-H 500ml (Hartmann solution)   Each 100 ml contains: Potassium Chloride 0.04gm, Sodium Lactate 0.32gm, Sodium Chloride 0.60gm, Calcium Chloride 2H20 0.027gm  25D1037  M/s Revive Pharmakon.   10-Km Raiwind Road Lahore. (DML # 000819)  DDCP Alert No. l77/2025 declared the sample as ‘substandard’ on the basis of Bacterial Endotoxin Test.  
      18.Infusion Parapals 100 ml Paracetamol USP 1g/100ml  PPV-384  M/s Inventor Pharma. Plot No. K/196, S.I.T.E Phase-II, Karachi (DML # 000866)  DDCP Alert No. l77/2025 declared the sample as ‘substandard’ on the basis of visible particulate matter.  
      19.Injection Freclomide Metoclopramide …… 10mg/2ml  25MC05  M/s Friends Pharma (Pvt) Ltd. 31-Km Ferozepur Road Lahore. (DML # 000681).  DDCP Alert No. l77/2025 declared the sample as ‘substandard’ on the basis of visible particulate matter & Sterility test.  
      20.Syrup Allerphene 120ml   Chlorpheniramine maleate ………………………2mg/5ml  4047  M/s P.D.H Pharmaceuticals (Pvt) Ltd.   19 Km Ferozepur Road Lahore. (DML # 000459)  DDCP Alert No. l79/2025 declared the sample as ‘substandard’ on the basis of the result of impurity (ethylene glycol) above the permissible limits.  
      21.Injection Aqua-P 5ml Sterile water for injection 5 mlP-676M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)  DDCP Alert No. l79/2025 declared the sample as ‘substandard’ on the basis of the result of visible particulate matter & Bacterial Endotoxin Test.  
      Risk Statement:The above-mentioned batches have been declared substandard due to serious quality defects including sterility failure, presence of bacterial endotoxins, visible particulate matter, and impurities such as ethylene glycol. Use of these defective medicines may lead to severe health risks including infections, sepsis, organ toxicity, or treatment failure.
      This alert particularly concerns patients receiving ophthalmic preparations, sterile injections/infusions (including antibiotics, metronidazole, paracetamol, vitamin K, and electrolyte solutions), as well as children and adults using oral syrups and suspensions. Healthcare professionals and the general public are advised to immediately stop use of the affected batches and report any adverse events.
      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 returned to the supplier/company.

      –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 – Unregistered / Illegal & Unsafe Sildenafil Tablets (PENAGRA, VEGA, COBRA) Being Sold Illegally

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        Rapid Alert

        CRACKDOWN AGAINST FALSIFIED / UNREGISTERED DRUGS

        Unregistered Indian-Origin Illegal & Unsafe Sildenafil Tablets (PENAGRA, VEGA, COBRA) Being Sold Illegally

        DRAP Alert NoNo I/S/09-25-62
        Action Date12th September, 2025
        Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
        2. Healthcare Professionals
        3. Pharmacies and medical stores
        Problem StatementDRAP has identified dangerous and illegal brands of Sildenafil tablets being sold in the market under the names PENAGRA 100 mg, VEGA 100 mg, and COBRA 125 mg tablets.
        Laboratory testing has declared PENAGRA substandard and all three products unregistered and falsified Indian-origin medicines. These tablets were being sold illegally by paddler in the local market, who has now absconded.

        Unregistered Drug Products Involved
        PENAGRA TABLETS 100 mg
        ·         Generic: Sildenafil 100 mg/tablet
        ·         Batch No.: BPTE-24134
        ·         Manufacturer (as per label): M/s BANSON PHARMACEUTICALS PVT. LTD.
        ·         Finding: Declared Substandard on basis of assay of sildenafil; also Unregistered (Falsified)
        VEGA 100 TABLETS
        ·         Generic: Sildenafil 100 mg/tablet
        ·         Batch No.: NIL (untraceable)
        ·         Manufacturer (as per label): M/s HAB PHARMACEUTICAL & RESEARCH INDIA
        ·         Finding: Declared Unregistered (Falsified)
         COBRA 125 MG TABLETS
        ·         Generic: Sildenafil 125 mg/tablet
        ·         Batch No.: BCB-98
        ·         Manufacturer (as per label): M/s Combitic Global Caplet Pvt. Ltd., India
        Finding: Declared Unregistered (Falsified)
        Risk StatementThe use of these unregistered brands of sildenafil tablets poses a serious threat to public health. Since PENAGRA has been declared substandard, patients may experience ineffective treatment, unpredictable dosing, or harmful side effects. In addition, PENAGRA, VEGA, and COBRA tablets are all unregistered and falsified products, which means they bypass DRAP’s strict quality, safety, and efficacy checks and may contain unsafe or misleading ingredients. Medicines obtained from the black market, paddlers, or online sellers are especially dangerous, as their authenticity and safety cannot be verified, putting patients at high risk of treatment failure and potential harm.
        Unregistered medicines are strictly prohibited in Pakistan and may cause serious health risks, including treatment failure and harmful side effects. The public is strongly advised: do not buy or use these unregistered products from pharmacies, online sellers, social media, or black market sources.
        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.

        Precautionary Recall of Inj. Cara-Fer (Iron Sucrose 100mg/5ml), Batch No. 24G001

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        Rapid Alert

        Precautionary Recall of Inj. Cara-Fer (Iron Sucrose 100mg/5ml), Batch No. 24G001

        DRAP Alert NoNo I/S/09-25-61
        Action Date12th September, 2025
        Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
        2. Healthcare Professionals
        3. Pharmacies and medical stores
        Problem StatementThe Drug Regulatory Authority of Pakistan (DRAP) has received reports through the Directorate of Drugs Control, Punjab, regarding multiple serious adverse drug reactions (ADRs) in patients administered Inj. Cara-Fer (Iron Sucrose 100mg/5ml), Batch No. 24G001, manufactured by M/s Caraway Pharmaceuticals, Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat.
        Reported cases include hypersensitivity reactions such as rash, angioedema, shortness of breath, hypotension, and palpitations, which indicate potential risk of life-threatening anaphylactic events.
        Risk StatementUse of Inj. Cara-Fer (Iron Sucrose 100mg/5ml), Batch No. 24G001 may result in serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, especially in patients receiving intravenous iron therapy. This batch is therefore classified as a Class I (High-Risk) Recall.
        Action InitiatedAll 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 Professionals·         Immediately stop use and dispensing of Inj. Cara-Fer (Iron Sucrose 100mg/5ml), Batch No. 24G001.
        ·         Identify and monitor patients who may have received this batch for signs of hypersensitivity or anaphylaxis.
        ·         Retain and segregate any remaining stock and ensure it is not used until further instructions.
        ·         Counsel patients regarding the risks and advise on suitable therapeutic alternatives where necessary.

        DRAP 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 UNLICENSED / UNAUTHORIZED MANUFACTURERS

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        Rapid Alert

        CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

        DRAP Alert NoNo I/S/09-25-60
        Action Date10th September, 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) informed the Drug Regulatory Authority of Pakistan that the following purported drug product has been declared ‘spurious’ upon analysis and reportedly manufactured by entity not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under:

        The product identification details are as under: –

        Therapeutic Good Affected:-

        S#Product NameBatch No.Purported ManufacturerRemarks
         1PAYODEN Solution 60mL
        Each 100ml contains: Povidone-Iodine.10.0g eq. to 1.0g available Iodine (1%w/v)        		006Purported to be manufactured by an unlicensed /illegal entity claimed to be M/s MSL Laboratories Industrial Area, Karachi.Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 171/2025)
        Risk StatementPurported drug product has been confirmed as falsified/spurious, as manufactured by entity neither licensed nor authorized by the Drug Regulatory Authority of Pakistan (DRAP). This product being illegally manufactured and marketed without regulatory oversight, rendering their quality, safety, and efficacy highly doubtful. Laboratory testing has revealed the absence of active pharmaceutical ingredient, indicating a complete lack of therapeutic value. The circulation and use of such unregulated product pose a serious risk to public health, including treatment failure, disease progression, and potential life-threatening consequences. The public is strongly advised to avoid the use of these unregistered drug products and report any suspicious or unauthorized medicines to DRAP through its official reporting channels.
        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 – SPURIOUS / FALSIFIED DECLARED BY PROVINCIAL LABORATORIES.

        Ahsan Hafiz Recall Alerts
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        Rapid Alert

        CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

        DRAP Alert NoNo I/S/09-25-59
        Action Date10th September, 2025
        Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
        2. Healthcare Professionals
        3. Pharmacies and medical stores
        Problem StatementDrug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared ‘Spurious’ as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under:

        The product identification details are as under: –

        Therapeutic Good Affected:-

        S#Product NameBatch No.Purported ManufacturerRemarks
        1TABLET ONSET-8 (REG # 025989)   Each Tablet Contains: ondansetron HCl eq. To ondansetron 8 mg)  447Purported to be manufactured by M/s Pharmedic Laboratories (Pvt) Ltd. (DML # 000228) 16 Km Multan Road Lahore. .Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976.  
        2Capsule Nexum (Reg # 033891)   EACH Capsule contains: ENTERIC-COATED PELLETS OF ESOMEPRAZOLE MAGNESIUM TRIHYDRATE EQUIVALENT TO ESOMPERAZOLE 40 MG)C02085Purported to be manufactured by M/s GETZ PHARMА (PVT) LIMITED., PLOT NO. 01, SECTOR 25, KORANGI INDUSTRIAL AREA. KARACHI.Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976.  
        3Capsule Maxflow -D (Reg # 033891)   EACH Capsule contains: Extended release pellets of Tamsulosin HCl eq. to Tamsulosin HCl …… 0.4mgQM375Purported to be manufactured by M/s CCL Pharmaceuticals (Pvt.) Ltd. (DML # 000052) 62 Industrial Estate Kot Lakhpat Lahore.Drug Testing Laboratory, Multan Punjab declared the purported drug product as ‘Spurious with regard to Dutasteride, misbranded with regard to labelling & substandard on basis of dissolution test and assay of tamsulosin HCl’.  
        4Capsule Azomax 250 mg   Each Capsule contains: Azithromycin (as di-hydrate) …………………… 250 mg  C3193Purported to be manufactured by M/s AGP Ltd. (DML # 000348) Plot No. B-23 Sindh Industrial Trading Estate Karachi.Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 171/2025)
        5Tablet Rigix  Each film coated tablet contains: Cetirizine hydrochloride…….10mg  C3905 C3362Purported to be manufactured by M/s AGP Ltd. (DML # 000348) Plot No. B-23 Sindh Industrial Trading Estate Karachi. (Recovered from unauthorized person / paddler)Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. Note: The unit carton bears batch # C3905 while blister bears Batch # C3362. (DDCP Alert No. 171/2025)  
        6Fexet Tablet 120mg  Each film coated tablet contains: Fexofenadine hydrochloride. ….120mg  F26018Purported to be manufactured by M/s Getz Pharma (Pvt) Limited., Plot No. 01, Sector 25, Korangi Indsustrial Area, Karachi.Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 171/2025)
        7Capsule Zetro 250 mg Each Capsule contains: Azithromycin (as dihydrate) ……..250 mg247C21Purported to be manufactured by M/s Getz Pharma (Pvt) Limited., 29-30 Sector 27 Korangi Industrial Area Karachi. (Recovered from unauthorized person / paddler)Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 171/2025)
        8Tablet Duphaston Each film coated tablet contains: Dydrogesterone … 10mg241476Purported to be manufactured by M/s Highnoon Laboratories Ltd. 17.5 Km Multan Road Lahore. (DML # 000155) (Recovered from unauthorized person / paddler)Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 176/2025)  
        9Tablet Danzen DS Each enteric coated tablet contains: Serratiopeptidase 10 mg (20,000 units of Serratiopeptidase)3602Purported to be manufactured by M/s Helix Pharma (Pvt) Ltd. A/56 SITE Mangopir Karachi. (DML # 000030) (Recovered from unauthorized person / paddler)Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 176/2025)  
        10Tablet Terbisil Each Tablet contains: Terbinafine (as HCl)  250 mg473Purported to be manufactured by M/s Saffron Pharmaceuticals (Pvt) Ltd. (DML # 000616) 19-Km Sheikhupura Road Faisalabad.  (Recovered from unauthorized person / paddler)Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 176/2025)
        11Tablet Terbisil Each Tablet contains: Terbinafine (as HCl)  250 mg473Purported to be manufactured by M/s Helix Pharma (Pvt) Ltd. A/56 SITE Mangopir Karachi. (DML # 000030) (Recovered from unauthorized person / paddler)Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 176/2025)
        12Tablet Azomax 500 mg Each film coated tablet contains : Azithromycin (as di-hydrate) ……..500 mgC3670Purported to be manufactured by M/s AGP Ltd. (DML # 000348) Plot No. B-23 Sindh Industrial Trading Estate Karachi. (Recovered from unauthorized person / paddler)Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 178/2025)
        13Tablet Prism 10 mg Each tablet contains: Escitalopram oxalate eq. to escitalopram ……. 10 mg25PR02Purported to be manufactured by M/s Friends Pharma (Pvt) Ltd. (DML # 000531) 31-Km Ferozepur Road Lahore. (Recovered from unauthorized person / paddler)Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 178/2025)
        14Capsule Gabica 300mg Pregabalin l00mg427C27Purported to be manufactured by M/s Getz Pharma (Pvt) Limited., 29-30 Sector 27 Korangi Industrial Area Karachi. (Recovered from unauthorized person / paddler)Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 178/2025)
        15Tablet Ativan 2 mg Each tablet contains: Lorazepam …… 2 mg 17C7019Purported to be manufactured by M/s Pfizer Pakistan Ltd. B-2, S.I.T.E. Karachi. (Recovered from unauthorized person / paddler)Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 178/2025)
        16Injection ONSET 4 ml   ondansetron HCl eq. To ondansetron 2mg/ml)  829Purported to be manufactured by M/s Pharmedic Laboratories (Pvt) Ltd. (DML # 000228) 16 Km Multan Road Lahore. (Recovered from unauthorized person / paddler) .Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ and ‘substandard’ on the basis of assay. (DDCP Alert No. 178/2025)
        Risk StatementAll the above mentioned purported drug products are confirmed as falsified/spurious/substandard, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. Laboratory testing has revealed that the product contains Low / no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately.
        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.