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RECALL ALERT -TABLET AMLOshine (all strengths & batches) – Sunshine Pharmaceuticals

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Immediate Withdrawal of all batches of AMLOshine Tablet 5mg (Reg # 062420) & Tablet AMLOshine 10 mg (Reg. # 062419)

manufactured by M/s Sunshine Pharmaceuticals

DRAP Alert NoNo II/S/09-25-80
Action Date26 September, 2025.
Target Audience– National Regulatory Field Force.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue In continuation to DRAP Alert No. NoII/S/05-25-45 dated 2nd June 2025, wherein three batches (7840, 7623, 7361) of Tablet AMLOshine 5mg [contains Amlodipine (as Beysalte) 5mg] bearing Reg. # 62420, and manufactured by M/s Sunshine Pharmaceuticals. Emanabad, G.T. Road, Gujranwala (DML # 000662) declared ‘substandard’ by Provincial Drug Testing Laboratory on the basis of impurities testing.
The panel of inspectors of DRAP accordingly conducted inspection at manufacturing unit of M/s. Sunshine Pharmaceuticals, Khan Payara, Near Saim Nala, Emanabad, Gujranwala, revealed multiple critical non-compliances with Good Manufacturing Practices (GMP). These included the absence of vendor qualification, failure to perform impurities testing and analytical method validation, unjustified use of API overages, lack of process validation, failure to investigate assay deviations observed in stability data, and the non-availability of impurity reference standards. The panel advised firm to initiate an immediate recall of all batches of AMLOshine Tablet 5mg (Reg # 062420) & Tablet AMLOshine 10 mg (Reg. # 062419).
Registration of Tablet AMLOshine 5 mg (Reg. #062420) and Tablet AMLOshine 10 mg (Reg. # 062419) are under suspension proceedings.
Risk Statement:The presence of impurities, lack of validated testing, and failure to investigate assay deviations in AMLOshine Tablets may compromise product quality, leading to reduced therapeutic efficacy and potential treatment failure in patients requiring amlodipine for hypertension and cardiovascular conditions. Such deficiencies may also expose patients to unpredictable adverse effects, particularly among the elderly, long-term users, and those with comorbidities. In view of the nature of defect and potential health risks, the issue is classified as a Class II Recall, as the defect may cause illness or treatment failure but is not considered immediately life-threatening.
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 – DRUG PRODUCTS (CLASS – I).

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    DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

    DRAP Alert NoNo I/S/09-25-79
    Action Date25 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 drug products have been declared as ‘Substandard’.

    Therapeutic Goods (s) Affected: –

    S#Product NameBatch No.ManufacturersRemarks
    1.Injection. Lignozin-A 2mL Each ml ampoule contains: Lignocaine HCI B.P…….. 20mg Adrenaline B.P………….1:80,000LG-001M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)“Misbranded” as per Section 3(s)(iv) of The Drugs Act 1976 and “Sub-Standard” on the basis of Physical Test i.e Physical Description Test (Visible Particles), pH Test & Assay of Adrenaline.
    2.Satamin Injection Each ampoule contains: (Mecobalamin J.P) 500ugMC24-030M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734).‘Adulterated’ as per Section_3 (a) (v) of The Drugs Act 1976.
    Risk Statement:The defects identified in the sampled injections pose serious risks to patient safety and therapeutic effectiveness. Injection Lignozin-A 2 mL (Batch LG-001) manufactured by M/s Trigon Pharmaceuticals (Pvt.) Ltd. has been declared Misbranded under Section 3(s)(iv) of the Drugs Act, 1976, and Substandard on the basis of physical description (visible particles), pH, and assay of adrenaline, raising concerns of compromised sterility, safety, and efficacy. Similarly, Satamin Injection (Batch MC24-030) manufactured by M/s Saturn Pharmaceuticals (Pvt.) Ltd. has been declared Adulterated under Section 3(a)(v) of the Drugs Act, 1976, which represents a severe violation of product quality and purity standards. The circulation and use of these defective products may lead to therapeutic failure, unpredictable adverse reactions, and potential harm to patients, warranting urgent regulatory and recall action.
    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 – TABLET ASCARD-75 (Batch # AR046L)

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      DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

      DRAP Alert NoNo II/S/09-25-78
      Action Date23 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 drug products have been declared as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      S#Product NameBatch No.ManufacturersRemarks
      1.Tablet Ascard-75   Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin BP)……………75 mgAR046LM/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000188)‘Sub-Standard’ with regards to Related Substances Test (Impurity C: Salicylic Acid).
      Risk Statement:The Drug Testing Laboratory has declared the given sample as ‘substandard’ on basis of failure in the Related Substances Test, showing the presence of Impurity C (Salicylic Acid) beyond the permissible pharmacopeial limits. The presence of such impurity may lead to adverse effects including gastric irritation and related complications, particularly in sensitive patient populations. While not considered immediately life-threatening, this defect poses a significant quality concern that may cause temporary or medically reversible adverse health consequences.
      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 (Tablet Ascard-75) Batch # AR021L

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        PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

        DRAP Alert NoNo II/S/09-25-77
        Action Date23 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 drug products have been declared as ‘Substandard’.

        Therapeutic Goods (s) Affected: –

        S#Product NameBatch No.ManufacturersRemarks
        1.Tablet Ascard-75   Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin BP)……………75 mgAR021LM/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000188)‘Sub-Standard’ with regards to Related Substances Test (Impurity C: Salicylic Acid).
        Risk Statement:The Drug Testing Laboratory has declared the given sample as ‘substandard’ on basis of failure in the Related Substances Test, showing the presence of Impurity C (Salicylic Acid) beyond the permissible pharmacopeial limits. The presence of such impurity may lead to adverse effects including gastric irritation and related complications, particularly in sensitive patient populations. While not considered immediately life-threatening, this defect poses a significant quality concern that may cause temporary or medically reversible adverse health consequences.
        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 – Substandard drug Products

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          PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

          DRAP Alert NoNo I/S/09-25-76
          Action Date23 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 drug products have been declared as ‘Substandard’.

          Therapeutic Goods (s) Affected: –

          S#Product NameBatch No.ManufacturersRemarks
          1.Injection. Lignozin-A 2mL Each ml ampoule contains: Lignocaine HCI B.P…….. 20mg Adrenaline B.P………….1:80,000LG-001M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)The Sample is declared as “Misbranded” as per Section 3(s)(iv) of The Drugs Act 1976 and “Sub-Standard” on the basis of Physical Test i.e Physical Description Test (Visible Particles), pH Test & Assay of Adrenaline.
          2.Aqua-P Injection Sterile water for injection 5mlP-679M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)‘Sub-standard’ on the basis of “Visible particulate matter” as per USP.
          3.Neocobal Injection 0.5 mg Each ml contains: Mecobalamin.0.5 mgS-2705M/s Pulse Pharmaceuticals (Pvt) Ltd. Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564)‘Substandard’ with regards to Assay and ‘Adulterated’ as per Section 3 (a) (v) of The Drugs Act 1976.
          4.Kanadex-N Cream   Each gram contains: 1 mg of dexamethasone-21 phosphate in the form of disodium salt U.S.P. 3500 i.u. of Neomycin in the form of Sulphate U.S.P.)F7-27  M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126)‘Substandard’ with regards to Assay of Dexamethasone Phosphate and Adulterated as per Section 3 (a) (v) of The Drugs Act 1976.
          5.Remedy Injection 500 mcg   Each 1ml ampoule contains: 500mcg of MecobalaminR-2419M/s Pak Risen Pharmaceuticals. Plot No. 3 Block B Phase-I-II Industrial Estate Hattar. (DML # 000573)‘Adulterated’ as per Section 3 (a) (v) of The Drugs Act 1976.
          Risk Statement:The presence of visible particles, failed assays, incorrect active ingredient levels, and adulteration with undeclared or unsafe components renders these medicines unsafe, ineffective, and potentially harmful to patients. Their use may result in treatment failure, unpredictable adverse effects, and serious safety risks including allergic reactions, infections, or toxicity.
          Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of 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 – PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

            Ahsan Hafiz Recall Alerts

            Recall Alert

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            PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

            DRAP Alert NoNo I/S/09-25-75
            Action Date19th September, 2025.
            Target Audience– National Regulatory Field Force.
            – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
            – General Public
            Problem / Issue Drug Testing Laboratory Faisalabad has informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug product has been declared as ‘Substandard’.

            Therapeutic Goods (s) Affected: –

            S#Product NameBatch No.ManufacturersRemarks
            1.Wisdom powder for injection (Ceftriaxone 500mg)WSM-027Trigon Pharmaceuticals (Pvt.) Ltd., Thokar-Raiwind road, Lahore.Substandard on the basis of failure of sterility test.
            Risk Statement:Use of the affected batches of Ceftriaxone Injection may pose a significant risk to patient safety. As this product is administered parenterally, compromised quality (such as sterility failure) can result in serious adverse health consequences. Potential risks include treatment failure, severe infection, sepsis, or life-threatening hypersensitivity reactions. Vulnerable populations, including neonates, children, and immunocompromised patients, are at particular risk of harm. Therefore, continued distribution or use of the defective product may lead to serious, sometimes fatal, health outcomes.
            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.

              VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

              Ahsan Hafiz Recall Alerts

              Recall Alert

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              VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

              DRAP Alert NoNo I/S/09-25-73
              Action Date18 September, 2025.
              Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
              ·         Healthcare Professionals-Veterinarians
              ·         Farmers/consumers
              Problem / Issue Drug Testing Laboratories from Provinces informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned Veterinary products have been declared as ‘Substandard’.

              Therapeutic Goods (s) Affected: –

              S#Product DetailsBatch #Manufacturer detailsRemarks
              1Inj. Rasomycin-5 50ml Oxytetracycline HCl – 50 mg /mlVM800    M/s Star Laboratories (Pvt) Ltd. 23 Km Multan Road Lahore. (DML # 000130)The Drug Testing Laboratory, Bahawalpur has declared the product ‘misbranded’ under Section 3(s)(iv) of the Drugs Act, 1976, and ‘substandard’ due to failure in the Bacterial Endotoxin Test.  
              2.Inj. Duralin -50 Oxytetracycline (as HCl) -50mg/ml5807M/s Mylabs (Pvt) Ltd. Khanka Sharif Tehsil and District Bahawalpur. (DML # 000747)The Drug Testing Laboratory, Multan has declared the product ‘misbranded’ under Section 3(s)(iv) of the Drugs Act, 1976, and ‘substandard’ due to failure in the  Sterility Test.
              Risk Statement:These quality defects directly compromise animal safety, therapeutic effectiveness, and indirectly pose risks to public health through the livestock production chain. Therefore, the products are classified as high-risk veterinary medicines requiring immediate regulatory attention.
              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, dairy owners, and animal keepers are strictly advised not to use these identified batches for their cattle or other livestock, as they may cause serious illness, infection, treatment failure, or even death in animals. If any of these batches have already been given, animals should be observed carefully for unusual symptoms such as fever, weakness, swelling at the injection site, or lack of recovery, and immediate veterinary assistance should be sought. Farmers are further advised to return such products to their supplier and use only safe, registered, and quality-assured veterinary medicines and vaccines to protect the health of their animals and avoid financial losses.

                RECALL ALERT – DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

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                Recall Alert

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                DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

                DRAP Alert NoNo I/S/09-25-72
                Action Date18th 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 drug products have been declared as ‘Substandard’.

                Therapeutic Goods (s) Affected: –

                S#Product NameBatch No.ManufacturersRemarks
                1.Satafenac Injection.     Each 3mL contains: Diclofenac Sodium (В.Р) 75mg    DS25-152M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734)The Drug Testing Laboratory, Lahore has declared the product ‘substandard’ on the basis of ‘visible particulate matter’.
                2.Infusion METROIN 100ML Metronidazole 500mg/100mlMT25-029
                &
                MT25-083                		M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734)The Drug Testing Laboratory, Bahawalpur has declared the Batch # MT25-029 of product as ‘substandard’ on the basis of ‘Bacterial Endotoxin test. & The Drug Testing Laboratory, Lahore has declared the Batch # MT25-083 of product as ‘substandard’ on the basis of ‘Particulate contamination: visible particles’ & ‘sterility test’
                3.Aqua-P Injection Sterile water for injection 5ml  P-678M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)  The Drug Testing Laboratory, Lahore has declared the product as ‘substandard’ on the basis of ‘visible particulate matter’ & ‘Bacterial endotoxin test’
                4.Injection Cara-Fer 5ml   Each ampoule (5ml) contains: iron sucrose complex eq. to elemental iron ………. 100mg (Reg # 052523)24G001M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629)The Drug Testing Laboratory Rawalpindi has declared the product as “Substandard” with respect to pH test, Turbidity test and Alkalinity test performed.
                Risk Statement:The defects identified include presence of visible particulate matter, bacterial endotoxin contamination, sterility failure, and particulate contamination. Use of such defective injectable products may pose serious health risks, including infection, sepsis, and adverse clinical complications, particularly in vulnerable patient populations. Healthcare professionals, distributors, and patients are strongly advised to stop the use of the above-mentioned batches immediately and follow DRAP’s recall and reporting procedures.
                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 – -VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

                  Ahsan Hafiz Recall Alerts

                  Recall Alert

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                  VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

                  DRAP Alert NoNo I/S/09-25-71
                  Action Date17 September, 2025.
                  Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
                  ·         Healthcare Professionals-Veterinarians
                  ·         Farmers/consumers
                  Problem / Issue Drug Testing Laboratories from Provinces informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned Veterinary products have been declared as ‘Substandard’.

                  Therapeutic Goods (s) Affected: –

                  S#Product DetailsBatch #Manufacturer detailsRemarks
                  1INJECTION VARIAX 100ML  
                  EACH ML CONTAINS:
                  VITAMIN A 15.000 I ,
                  VITAMIN D3 1,000 IU,
                  VITAMIN E 20MG,
                  VITAMIN B1 10MG,
                  VITAMIN B SODIUM PHOSPHATE 5MG,
                  VITAMIN B6 3MG.
                  NICOTINAMIDE 35MG,
                  PANTOTHENOL 25MG,
                  VITAMIN B12 50MCG                  		EI-1654  M/s. Eterna Pharma (Pvt) Ltd.   Plot No. 99, 100, 101 &198-C, Sector D1, Old Industrial Estate, Mirpur, AJK Pakistan. (DML # 000923) ‘Adulterated’ with respect to Assay test performed for Vìtamin B1 and is “Adulterated” as defined under clause (iv) of sub-section (a) of section 3 of The Drugs Act, 1976 as it contains Ascorbic Acid, Ambrosic Acid and Peiminine as ingredients other than the labelled ingredients.  
                  2Ivermex Injection 100 mL
                  Each ml contains Ivermectin …. 10 mg                  		IV348M/s Wimits Pharmaceuticals (Pvt) Ltd. Plot No. 129 Sundar Industrial Estate Lahore. (DML # 000789) ‘Substandard’ quality on the basis of the result of test for related substance, sterility & assay of Ivermectin.  
                  3PRIMOX injectable suspension 50mL
                  Each ml contains
                  amoxicillin (as trihydrate) …. 150 mg                  		PP9789M/s Prix Pharmaceutical (Pvt) Ltd.   Plot No. 5 Pharmacity 30-Km Multan Road Lahore. (DML # 000587) ‘Substandard’ quality on the basis of the result of sterility test.
                  4Injection Lumpyvac 50  
                  After reconstitution, each 2ml dose contains:
                  Attenuated Lumpy Skin Disease Virus (Neethling strain) ……. ≥103.5 TCID50    

                  Diluent for Lumpy Skin Disease Vaccine for Cattle (For Veterinary Use)
                  Potassium Chloride 0.2mg
                  Potassium Phosphate monobasic 0.2 mg
                  Sodium Chloride 0.8mg,
                  Sodium Phosphate dibasic 1.14mg per 2 mL (Reg # 111128)                    		25/LSD/01Importer: M/s Huzaifa International. Commercial Area, Aziz Bhatti Town, Dist. Sargodha. Manufacturer: Vetal animal Health Product S.A Organize Sanayi Bolgesi, Petrol Mah. 14. Cad. No. 01, Adiyamam, Turkey   ‘Substandard’ on the basis of the result of sterility test.
                  5  Injection Oxytocin 50ml Oxytocin 10 IU/Ml
                  Reg# 014564                    		V-06725M/s Venus Pharma. 23-Km Multan Road. Lahore. (DML # 000300)‘Substandard’ on the basis of the result of sterility test.
                  6Injection Oxytovetz 50ml Oxytocin (USP) … 10 IU/mL
                  Reg. # 111468                  		25129639
                  M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)                  		‘Substandard’ on the basis of the result of sterility test.
                  Risk Statement:Use of the above-mentioned veterinary drug products poses serious risks to animal health and public safety:
                  ·   Treatment failure and loss of therapeutic efficacy in livestock.
                  ·   Microbial contamination leading to sepsis and animal deaths.
                  ·   Ineffective vaccination against Lumpy Skin Disease, increasing risk of outbreaks.
                  ·   Adverse economic impact on farmers due to animal health losses.
                  Food safety risks through compromised milk and meat supply chains.
                  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, dairy owners, and animal keepers are strictly advised not to use these identified batches for their cattle or other livestock, as they may cause serious illness, infection, treatment failure, or even death in animals. If any of these batches have already been given, animals should be observed carefully for unusual symptoms such as fever, weakness, swelling at the injection site, or lack of recovery, and immediate veterinary assistance should be sought. Farmers are further advised to return such products to their supplier and use only safe, registered, and quality-assured veterinary medicines and vaccines to protect the health of their animals and avoid financial losses.

                    Recall Alert – DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

                    Ahsan Hafiz Recall Alerts

                    Recall Alert

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                    DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

                    DRAP Alert NoNo I/S/09-25-69
                    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
                    1SN DOL Suspension 60ml.   Each 5ml contains: Paracetamol ……… 120 mg917M/s SNB Pharma (Pvt) Ltd. Plot No. 142 Industrial Estate Hayatabad Peshawar. (DML # 000759)‘Substandard’ on the basis of presence of impurity (Ethylene Glycol), above the permissible limit.
                    2SALBOVENT Oral syrup 60ml   Each 5ml contains Salbutamol (as sulphate) .. 2mgL25D52M/s Synchro Pharmaceuticals. 77-Industrial Estate Kot Lakhpat Lahore. (DML # 000575)‘Substandard’ on the basis of presence of impurity (Ethylene Glycol), above the permissible limit.
                    3RESGYL Suspension 60 ml   Each 5ml contains Benzoyl Metronidazole equivalent to Metronidazole ………… 200 mg  4E566M/s Rasco Pharma (Pvt) Ltd. 5.5 Km Raiwind Road Ali Razabad, Lahore. (DML # 000530)‘Substandard’ on the basis of presence of impurity (Ethylene Glycol), above the permissible limit.
                    4Tablet Daisy 10 mg   Each film coated tablet contains Cetirizine Dihydrochloride USP ………………………….10mg  258084 & 258085  M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore (DML # 000537)‘Substandard’ on the basis of Test for impurities (Organic impurities).
                    5Colchis Capsules   Each Hard Gelatin Capsule contains: Thiocolchicoside ……….4 mg15M/s Akson Pharmaceuticals (Pvt) Ltd. Plot No. 9B-1 & 2 Sector D-1 Old Industrial Estate Mirpur Azad Kashmir. (DML # 000486)‘Substandard’ on the basis of Assay and uniformity of weight.
                    6AQUA-P Injection (Sterile Water for Injection 5mL)  P-676 P-677M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)Drug Testing Laboratory, Lahore declared the sample as ‘substandard’ quality on the basis of the result of test for bacterial endotoxins.
                    7Sterile Water for Injection 10ml   Each Glass Ampoule contains: WFI …………………. 10mL084L24M/s Brookes Pharma (Pvt) Ltd. Plot No. 58-59 Sector No. 15 Korangi Industrial Area Karachi. (DML # 000275)‘Substandard’ on the basis of Bacterial Endotoxins Test.
                    8Sterile Water for injection 5 ml   Each Glass Ampoule contains: WFI …………………. 5 ml  130M/s Wilshire Laboratories (Pvt) Ltd. 124/1 Industrial Estate Kot Lakhpat Lahore. (DML # 000232)‘Substandard’ on the basis of Bacterial Endotoxins Test.  
                    Risk Statement:The above drug products have been declared substandard / adulterated due to toxic impurities, undeclared ingredients, assay failures, sterility issues, and bacterial endotoxins. Their use may cause treatment failure, harmful side effects, or serious health risks including infections and toxicity. Children, elderly, hospitalized, and immunocompromised patients are at greater risk. The public and healthcare providers are advised to stop use and return the affected batches immediately.
                    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.