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101. Recall Alert – Cream Kanadex-N (Batch # D7-22 & F7-27) – Substandard.

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert NoNo II/S/10-25-101
Action Date24 October, 2025.
Target Audience– National Regulatory Field Force.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Drug Testing Laboratory from Province informed that the sample of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#Product NameBatch No.ManufacturersRemarks
1.Cream Kanadex-N Each gram contains: Dexamethasone-21 phosphate in the form of disodium salt …………………………… 1mg Neomycin in the form of sulphate………………. 3500I.U (Reg.# 012475)  D7-22 & F7-27M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126)The sample is declared “Substandard” on the basis of the assay of Dexamethasone Phosphate (as disodium salt), and “Adulterated” on the basis of the identification and quantification of Dexamethasone (base) in HPLC analysis (0.343 mg/g), which is an undeclared active pharmaceutical ingredient not stated on the product label.
Risk Statement:The presence of an undeclared corticosteroid, coupled with sub-therapeutic potency of the declared active ingredient, may lead to unpredictable clinical outcomes, including reduced therapeutic efficacy, skin atrophy, hormonal disturbances, or systemic corticosteroid exposure, especially with prolonged use.
Patients suffering from eczema, dermatitis, and other inflammatory skin conditions, as well as children and individuals using topical steroids on large surface areas, are the most likely to be affected. The use of this defective product undermines treatment safety and effectiveness and may result in adverse dermatological or systemic effects.

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.

    100. Recall Alert – Veterinary Drug Products Declared Substandard.

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    VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG LABORATORIES, KARACHI.

    DRAP Alert NoNo I/S/10-25-100
    Action Date24 October, 2025.
    Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
    ·         Healthcare Professionals-Veterinarians
    ·         Farmers/consumers
    Problem / Issue Drugs Testing Laboratories from Provinces informed that the sample of below mentioned Veterinary products have been declared as ‘Substandard / Misbranded’.

    Therapeutic Goods (s) Affected: –

    S#Product DetailsBatch #Manufacturer detailsRemarks
    1.Injection Ivotek 100ml Each ml contains: Ivermectin……….10mg (Reg. # 016284)VM 957M/s Star Laboratories (Pvt.) Ltd. (Animal Health Care Division) 23 Km Multan Road Lahore. (DML # 000130)The sample is Sub-Standard with regards to Assay and Test for related substances.  
    2.Injection Ivergen 10ml Each ml contains: Ivermectin………10 mg (Reg. # 023432)607.IVM/s Symans Pharmaceuticals (Pvt) Ltd. 10-Km Sheikhupura Road Lahore. (DML # 000323)The sample is Sub-Standard with regards to Assay and Test for related substances.  
    3.Rasomycin-5 Injection 100 ml Each ml contains: Oxytetracycline HCl …. 50 mg (Reg. # 003791)VM406M/s Star Laboratories (Pvt.) Ltd. (Animal Health Care Division) 23 Km Multan Road Lahore. (DML # 000130)The sample is Misbranded with regards to labelling as defined under Section 3(s)(iv) of the Drugs Act,1976 and Substandard on the basis of Bacterial Endotoxin Test.  
    Risk Statement:Farmers, livestock owners, and veterinarians using these products for treatment of cattle, sheep, goats, and other farm animals are the groups most likely to be affected. The use of such defective medicines can result in loss of animal productivity, therapeutic failure, or potential residues in milk and meat, thereby posing economic and food-safety concerns for the public.
    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 VeterinarianThis alert applies strictly to the specific batches listed above and does not apply to other batches of the same products. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batches under any circumstances. In case any of the above-mentioned batches have already been administered, treated animals should be closely monitored for possible signs of infection, treatment failure, or adverse reactions, and appropriate supportive care must be provided. Any suspected adverse events or quality-related problems linked to these batches should be reported immediately to DRAP’s Pharmacovigilance Centre and to the Provincial Livestock & Dairy Development Departments. Practitioners are further advised to ensure that only alternative registered and quality-assured batches are used in veterinary practice.
    Advice for Farmers and Livestock OwnersFarmers, livestock owners, and animal handlers are advised not to use the above-mentioned batches of Injection Ivotek (Batch No. VM 957), Injection Ivergen (Batch No. 607.IV), and Rasomycin-5 Injection (Batch No. VM406). Discontinue use immediately if already in possession of these products and isolate any remaining stock.
    If the product has already been administered, observe animals closely for signs of fever, swelling at the injection site, weakness, or lack of therapeutic response, and consult a qualified veterinarian if any abnormal signs occur.
    Only purchase and use registered veterinary medicines obtained through licensed distributors or veterinary outlets. Return any suspected or recalled stock to the supplier and report details to the nearest Provincial Drug Control Office or the Drug Regulatory Authority of Pakistan (DRAP) for appropriate action.

      99. Recall Alert (Class-II)- Drug Products Declared Substandard.

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      DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

      DRAP Alert NoNo II/S/10-25-99
      Action Date22 October, 2025.
      Target Audience– National Regulatory Field Force.
      – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
      – General Public
      Problem / Issue Central Drugs Laboratory Karachi informed that the sample of below mentioned drug products have been declared as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      S#Product NameBatch No.ManufacturersRemarks
      1.Zolint Suspension Each 5ml contains: FURAZOLIDONE…… 25 mg Metronidazole ………. 75 mg (Reg. # 016494)25024M/s Libra (Pvt) Ltd. 77 Industrial Estate Hayatabad Peshawar. (DML # 000369)The sample has been declared ‘substandard’ on the basis of assay test of Furazolidone & Metronidazole.
      2.Cytobion Capsule Each capsule contains: Mecobalamin …… 500 mcg (Reg. # 062462)H575M/s Hoover Pharmaceuticals (Pvt) Ltd. Plot No.16 Zain Park Industrial Area Saggian By Pass Road Lahore. (DML # 000676)The sample has been declared ‘substandard’ on the basis of description test wherein dark red crystals not found in sample while description is white capsule containing almost white fine powder with dark red crystals.  
      Risk Statement:The use of these defective medicines may result in therapeutic failure and ineffective treatment, particularly affecting vulnerable groups such as children, elderly, diabetic, and anemic patients. Substandard quality of Zolint Suspension used for infectious diarrhea may lead to prolonged illness, dehydration, and microbial resistance, while the defective Cytobion Capsule used for neuropathies and Vitamin B12 deficiency may cause delayed neurological recovery and worsening of deficiency symptoms.
      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.

        98-Rapid Alert- Falsified / Unregistered Aphrodisiac Drug Product

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        Rapid Alert

        CRACKDOWN AGAINST FALSIFIED / SPURIOUS/ UNREGISTERED APHRODISIAC DRUG PRODUCTS

        DRAP Alert NoNo I/S/10-25-98
        Action Date22 October, 2025
        Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
        2. Healthcare Professionals
        3. Pharmacies and medical stores
        Problem StatementCentral Drugs Laboratory (CDL), Karachi informed that the following drug product have been declared ‘spurious/falsified/unregistered’ upon analysis and reportedly manufactured by entities not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under:
        S#Product NameBatch No.ManufacturerRemarks
        1.JUMBO 150mg Capsules Each Capsule contains: Sildenafil Citrate ……. 150mg  JUC-05M/s Combitic Global Caplet Pvt. Ltd. India‘Unregistered (Falsified)’ drug product
        2.  COBRA 150 Tablets Each tablet contains: Sildenafil Citrate ……. 150mg  CBT289M/s Combitic Global Caplet Pvt. Ltd. India‘Unregistered (Falsified)’ drug product
        3.BLACK COBRA 125 Tablets Each tablet contains: Sildenafil Citrate ……. 125mg  BOB96M/s Combitic Global Caplet Pvt. Ltd. India‘Unregistered (Falsified)’ drug product
        4.PENEGRA 100 Tablets Each tablet contains: Sildenafil Citrate ……. 100mgG400016M/s Zydus Lifesciences Limited, India.‘Unregistered (Falsified)’ drug product
        5.BLACK COBRA 250 Tablets Each tablet contains: Sildenafil Citrate ……. 250mg  BOR-31M/s Combitic Global, India.‘Unregistered (Falsified)’ drug product
        6.Super CIALIS 5mg Tablets Each tablet contains: Sildenafil Citrate ……. 250mg  205-113M/s HAB Pharmaceuticals & Research Limited, India.‘Unregistered (Falsified)’ drug product
        7.KNIGHT RIDER DELAY SPRAY Contains Lidocaine  S-A0110M/s Royal Herbal Ent. Co. Karachi.‘Unregistered (Falsified)’ drug product
        8.TOKO-D3 Cream Contains Lidocaine  62051M/s Mehran Homoeo Pharma, Mangora Swat.‘Unregistered (Falsified)’ drug product
        9.UD Cream Contains Lidocaine35924M/s Mehran Homoeo Pharma, Mangora Swat.‘Unregistered (Falsified)’ drug product

        The product identification details are as under: –

        Risk StatementThe above-mentioned products have been declared Unregistered and Falsified as they are not confirmed to have been manufactured, imported, or distributed through any supply chain duly authorized or licensed by the Drug Regulatory Authority of Pakistan (DRAP) or the respective Provincial Governments. The origin, composition, and quality of these products remain unverified; therefore, their safety and efficacy cannot be assured. The unregulated presence of such aphrodisiac preparations containing Sildenafil Citrate and Lidocaine poses significant public health risks, including potential cardiovascular complications, neurological adverse effects, and misuse in vulnerable populations. The continued sale or use of these products outside the legal distribution framework represents a serious threat to consumer safety and undermines regulatory control mechanisms intended to ensure the availability of genuine and quality-assured therapeutic goods.
        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.

        97- RECALL ALERT – VETERINARY DRUG PRODUCT DECLARED MISBRANDED

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        VETERINARY DRUG PRODUCTS DECLARED MISBRANDED BY CENTRAL DRUGS LABORATORY, KARACHI.

        DRAP Alert NoNo III/S/10-25-97
        Action Date22 October, 2025.
        Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
        ·         Healthcare Professionals-Veterinarians
        ·         Farmers/consumers
        Problem / Issue Central Drugs Laboratory informed that the sample of below mentioned Veterinary product has been declared as ‘Misbranded’.

        Therapeutic Goods (s) Affected: –

        S#Product DetailsBatch #Manufacturer detailsRemarks
        1.LISO-10 Powder Each gm Contains: – Lysozyme…….22% Vitamin E 50 SD…….0.5% (Reg. # 049566)IO E004M/s Mallard Pharmaceuticals (Pvt) Ltd. 23-KM Lahore Road Qadirpur, Multan. (DML # 000622)The sample has been declared ‘Misbranded’ under Section 3(s)(i) of the Drugs Act, 1976. as the Batch Number, Date of Manufacturing, Date of Expiry, and Retail Pricewerenot printed or written in indelible ink in a conspicuous manner on both the outer carton and the innermost sachet.
        Risk Statement:Use of a misbranded batch undermines the ability of healthcare professionals and consumers to verify product authenticity and shelf-life, posing potential risks of administering expired or improperly stored formulations. Veterinary practitioners, distributors, and retailers are therefore advised to immediately stop distribution, sale, or use of the affected batch, segregate existing stock, and verify labeling conformity before dispensing or prescribing.
        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 VeterinarianThis alert applies strictly to the specific batch listed above and does not apply to other batches of the same product. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batch under any circumstances.
        Advice for Farmers and Livestock OwnersFarmers and livestock owners are advised not to use LISO-10 Powder (Batch No. IO E004) that lacks proper labeling of batch number, manufacturing and expiry dates, or retail price, as such products cannot be verified for their authenticity, quality, or safety. Using an untraceable or expired product may reduce its effectiveness in protecting animal health and may even cause adverse reactions or treatment failure.
        Always ensure that veterinary medicines are purchased only from licensed veterinary stores or authorized distributors, and that each pack clearly displays the batch number, expiry date, and manufacturer details in permanent ink. If any pack is found without proper labeling, stop its use immediately, retain the sample, and report the issue to the nearest Drug Control Authority or veterinary officer for regulatory follow-up and replacement through authorized channels.

          96. RAPID ALERT – FALSIFIED / SPURIOUS – CIALIS®

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          Rapid Alert

          CRACKDOWN AGAINST FALSIFIED / SPURIOUS – CIALIS®

          DRAP Alert NoNo I/S/10-25-96
          Action Date20th October, 2025
          Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
          2. Healthcare Professionals
          3. Pharmacies and medical stores
          Problem StatementCentral Drugs Laboratory certified that Cialis® 20 mg Tablet bearing Batch # 24576 purported to be manufactured by M/s Eli Lilly and Company Limited, & Cialis® 20 mg Gold (Batch # MAL 19990546AG) purported to be manufactured by M/s Lilly ICOS, USA are “Falsified & spurious” identified in the Pakistani market. The reported Brands & batch numbers are not imported, manufactured, or supplied by the manufacturers mentioned on the label. The packaging falsely uses the name and branding, but it does not come from any authorized supply chain.

          The product identification details are as under: –

          Risk StatementThese falsified and spurious products pose a significant health risk to the public. Since the brands & batches have not been imported or supplied through any authorized or traceable source, its actual composition, safety, and efficacy remain unknown. Individuals who may have purchased this product from unauthorized medical stores, online platforms, or informal supply chains are at particular risk of exposure to unverified and potentially harmful ingredients. Use of such falsified medicine can lead to serious adverse health effects, therapeutic failure, or toxic reactions, especially among patients with cardiovascular or metabolic conditions.

          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.