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95. Recall Alert – Veterinary Drug Product declared Substandard.

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VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert NoNo I/S/10-25-95
Action Date16th October, 2025.
Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
·         Healthcare Professionals-Veterinarians
·         Farmers/consumers
Problem / Issue Drug Testing Laboratory from Province informed the Drug Regulatory Authority of Pakistan that the sample of below mentioned Veterinary product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#Product DetailsBatch #Manufacturer detailsRemarks
1.Oxytocin Injection 50ml
Oxytocin Synthetic 10-IU/mL
(Reg. # 019928)		V8-5M/s ISIS Pharmaceutical & Chemical Works.  25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126)The sample is declared “sub-standard” on the basis of Sterility testing.
Risk Statement:The use of Oxytocin Injection 50 ml (Batch No. V8-5) declared sub-standard on the basis of sterility testing, poses a significant risk to livestock health and animal productivity. As Oxytocin is commonly administered to dairy animals such as cows and buffaloes to induce milk let-down and facilitate parturition, use of a non-sterile injection may lead to severe local infections, fever, abscesses, or systemic septicemia in treated animals. This can result in economic losses to farmers and potential contamination of milk supply. All veterinarians, livestock owners, and distributors are therefore advised to immediately discontinue the use and sale of the affected batch and ensure that only quality-assured and sterile veterinary injectable preparations are procured from licensed sources.
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.

    94. Recall Alert (Class-II) – Substandard Drug Products.

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    DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

    DRAP Alert NoNo II/S/10-25-94
    Action Date16th October, 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 sample of below mentioned drug product has been declared as ‘Substandard’.

    Therapeutic Goods (s) Affected: –

    S#Product NameBatch No.ManufacturersRemarks
    1.Kanabax Cream 15gm Each Gram contains: Dexamethasone ………… 1mg Neomycin sulphate ……… 3.5mgKNX-272M/s Baxter Pharmaceuticals. A-1/A Scheme No. 33 Phase-I S.I.T.E. Super Highway Karachi. (DML # 000700)The sample is declared as “misbranded” with regards Labelling as per Section 3(s)(iv), ‘adulterated’ with regards to Section 3(a)(iv) of the Drugs Act,1976 & ‘substandard’ on the basis of Assay of Dexamethasone Phosphate.
    2.Zysic Tablet 10 mg Each film coated tablet contains: Cetirizine HCI (USP) … 10mg727M/s Jinnah Pharmaceuticals (Pvt) Ltd. 13-Km Lahore Road Multan. (DML # 000578)‘Sub-Standard’ with regards to Impurities Test.
    Risk Statement:Use of Kanabax Cream (Batch No. KNX-272), declared misbranded, adulterated, and substandard, may lead to ineffective treatment, worsening of skin infections, or antimicrobial resistance, particularly in children and patients with chronic skin conditions. Similarly, Zysic Tablet 10 mg (Batch No. 727), found substandard due to impurities, may cause reduced efficacy or mild adverse effects in allergic or asthmatic individuals. Consumers are advised to avoid these batches and seek medical advice if already used.
    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.

      93. Recall Alert- Syrup Synadin 60ml (Batch # L24K110) -Substandard

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      DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

      DRAP Alert NoNo I/S/10-25-93
      Action Date16th October, 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 sample of below mentioned drug product has been declared as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      S#Product NameBatch No.ManufacturersRemarks
      1.Syrup Synadin 60ml Loratadine: 5mg/5mlL24K110M/s Synchro Pharmaceuticals.  77-Industrial Estate Kot Lakhpat Lahore. (DML # 000575)The sample is declared as “sub-standard” on the basis of Physical Description Test, Assay Test & it contains the impurity Ethylene Glycol above the permissible limit.
      Risk Statement:Use of Synadin Syrup (Batch No. L24K110), declared substandard due to assay failure and presence of ethylene glycol impurity above permissible limits, poses a potential toxic risk, especially for children who are the primary users of antihistamine syrups. Consumers and healthcare providers are advised to immediately stop use of these batches and report any adverse events to DRAP or concerned authorities.
      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 Cloferd 50 mg (Batch # 6926) declared Substandard.

        Ahsan Hafiz Recall Alerts

        Recall Alert

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        DRUG PRODUCT DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

        DRAP Alert NoNo II/S/10-25-90
        Action Date15th October, 2025.
        Target Audience– National Regulatory Field Force.
        – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
        – General Public
        Problem / Issue Provincial Health Department 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 Cloferd 50 mg
        Each film coated tablet contains:
        Clomiphene Citrate .. 50mg (Reg. # 066676)        		6926M/s Medizan Laboratories (Pvt) Ltd.
        Plot No 313 Industrial Triangle Kahuta Road Islamabad. (DML # 000572)        		The Sample is declared as “Sub-Standard” on the basis of Dissolution Test.
        Risk Statement:Clomiphene Citrate is indicated for the treatment of female infertility and ovulatory disorders. Use of a substandard product with inadequate dissolution may lead to reduced therapeutic efficacy, resulting in failure of ovulation induction, delayed conception, or treatment frustration in women of reproductive age undergoing fertility management. Timely identification and withdrawal of the affected batch are essential to prevent therapeutic failure and ensure patient safety.
        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 – Adulterated Tablet Virtec 10 mg (Batch # FK-24-007)

          Ahsan Hafiz Recall Alerts

          Recall Alert

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          DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

          DRAP Alert NoNo I/S/10-25-89
          Action Date15th October, 2025.
          Target Audience– National Regulatory Field Force.
          – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
          – General Public
          Problem / Issue Provincial Health Department 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.Тablet Virtec
          Each film coated tablet contains:
          Cetirizine Dihyrochloride 10 mg
          (Reg # 021870)          		FK-24-007M/s Don Valley Pharmaceuticals (Pvt) Ltd.
          31-Km Ferozepur Road Lahore.
          (DML # 000395)          		Sample is “Adulterated” as defined under clause (iv) of sub-section (a) of section 3 of The Drugs Act, 1976 as it contains “Paracetamol” as an ingredient a substance other than the prescribed substance i.e., Cetirizine Hydrochloride.
          Risk Statement:The presence of an undeclared pharmacologically active substance poses a serious risk to patient safety, as it may lead to unintended therapeutic effects, drug interactions, or dosing errors, particularly in patients concurrently taking Paracetamol-containing preparations or with hepatic impairment.
          This adulteration compromises the safety, efficacy, and quality of the product and indicates a critical lapse in manufacturing and quality assurance systems at the firm.
          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 declared substandard

            Ahsan Hafiz Recall Alerts

            Recall Alert

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            DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

            DRAP Alert NoNo I/S/10-25-86
            Action Date09th October, 2025.
            Target Audience– National Regulatory Field Force.
            – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
            – General Public
            Problem / Issue Provincial Health Departments 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 Rolekast 10mg   Each film coated tablet contains: Montelukast (as Sodium)…10 mg1397M/s Roryan Pharmaceutical industries (Pvt) Ltd. 85-B Hayatabad Industrial Estate Peshawar.  (DML # 000566)The sample is declared as “Sub-Standard” on the basis of Dissolution Test and impurities test.
            2.AME-CLOP Injection Each 2mL contains: Metoclopramide HCL….10mgMC-126M/s Ameer Pharma (Pvt) Ltd. 23-Km Sheikhupura Road, Lahore. (DML # 000604)sample is ‘Sub-Standard’ on the basis “Particulate contamination: visible particles” as per BP.
            3.Infusion DORCIP Each ml contains: Ciprofloxacin (as Lactate)….2mgDC-120M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)The Sample is declared as “Sub-Standard” on the basis of Visible Particulates, pH Test, Sterility Test and Bacterial Endotoxin Test (BEТ).  
            Risk Statement:Tablet Rolekast 10 mg (Batch 1397), used for asthma and allergic rhinitis in children and adults, has failed dissolution and impurity tests. AME-CLOP Injection (Batch MC-126), used for severe nausea, vomiting and gastrointestinal disorders in patients including pregnant women, surgical and chemotherapy cases, contains visible particles posing risk of embolism and infection and DORCIP Infusion (Batch DC-120), used in serious infections among adults and  critically ill patients, failed sterility, endotoxin and pH tests, risking sepsis and life-threatening reactions. Use of these defective medicines can cause ineffective treatment, adverse reactions, and serious safety hazards. Healthcare providers and distributors must immediately stop use and sale, quarantine affected stock, and return it to the supplier, while patients should discontinue these batches and seek medical advice if exposed.
            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 (Substandard)

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              Recall Alert

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              VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

              DRAP Alert NoNo I/S/10-25-84
              Action Date09th October, 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 Micrise-2% 50ml Ivermectin: 20 mg/mlMR-075  M/s Biorise Pharmaceuticals. 19-Km, Lahore Road, Multan. (DML # 000934)The sample is declared as “Sub-Standard” on the basis of Assay Test and Chromatographic Purity Test.  
              2.Injection Ivozon 2% 10 ml Ivermectin: 20 mg/mlAP/INJ-G/25-83M/s. Amazon Pharmaceutical (Pvt) Ltd.  Plot No. 10/A & 29/B, Small Industrial Estate, Bhimber, AJK (DML # 000975)  The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
              3.Injection IVERMEC 1% 50ml Ivermectin: 10 mg/mlGI – 25E 140M/s Grand Pharma (Pvt) Ltd. Plot No. 5-A Street No. N-5 National Industrial Zone Rawat (DML # 000680)  The sample is declared as “Sub-Standard” on the basis of Chromatographic Purity Test.
              4.Injection Selmec 50 ml Ivermectin: 20 mg/ml  SN-116M/s Selmore Pharmaceuticals (Pvt) Ltd. 36 Km Off. Multan Road Lahore. (DML # 000507)  The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.  
              5.Injection Ivomek 2% 10 ml Ivermectin: 20 mg/mlNI-807M/s Nawal Pharmaceuticals. Plot No. 11-A Punjab Small Industrial Estate Taxila. (DML # 000735)  The sample is declared as ‘Misbranded’ as per section 3(s)(vi) of the Drugs Act 1976 & 3(g)(i) of the Drugs (Labelling and Packing) Rules 1986, and “Substandard” on the basis of Assay Test and Chromatographic Purity Test.  
              6.Injection Ivergen 50ml Ivermectin: 10 mg/ml594.IVM/s Symans Pharmaceuticals (Pvt) Ltd. 10-Km Sheikhupura Road Lahore. (DML # 000323)The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances
              7.Injection Fosphovetz Each ml contains: Butaphosphan (MS)……100mg Cyanocobalamine (B.P)..50mcg Taurine (USP)……………37.3mg Nicotinamide (B.P) ……….23mg DL-Methionine (B.P) ….18.7mg  24119013M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)The Sample is declared as “Sub-Standard” on the basis of Assay of Cyanocobalamine and Bacterial Endotoxin Test (BET).
              8.Oxyvetz 5% 100ml Injection   Each ml contains: Oxytetracycline HCI BP….50mg25157083M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)Sample is ‘Sub-standard’ with regards to Bacterial Endotoxins Test and Misbranded with regards to Labelling (as per Section 3 (s) (iv) of The Drugs Act 1976).
              Risk Statement:Laboratory testing identified serious quality defects including assay failure, excessive impurities/related substances, misbranding of label information, and failure of bacterial endotoxin and sterility-related tests.
              These medicines are widely used for livestock and food-producing animals (e.g., cattle, sheep, goats) for parasitic control, metabolic support, and infection treatment. Their use can lead to ineffective therapy, toxic reactions, contamination risk, and unsafe drug residues in milk and meat, posing both animal health and public health hazards. 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 – Orange Auto disable Syringes 5mL (Batch # S5102402), DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

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                MEDICAL DEVICE DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

                DRAP Alert NoNo I/S/09-25-82
                Action Date30 September, 2025.
                Target Audience– National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
                – Healthcare Professionals – Physicians, Pharmacists, and Nurses.
                – General Public
                Problem / Issue Central Drugs Laboratory (CDL) Karachi, has declared the sample of below mentioned Medical Device as ‘Substandard’.

                Therapeutic Goods (s) Affected: –

                S#Product NameBatch No.ManufacturersRemarks
                1.Orange Auto disable Syringes 5ml
                (MDMR # 000078)                		S5102402M/s Silver Surgical Complex (Pvt) Ltd,
                C-40, S.I.T.E II, Super Highway Industrial Area Scheem 33, Karachi.
                (ELM # 0007)                		Sample has been declared of ‘substandard’ quality on the basis of results for Auto disable feature.
                Risk Statement:This defect poses a high risk of reuse of syringes, which may result in cross-contamination and transmission of bloodborne infections such as HIV, hepatitis B, and hepatitis C. Because the defect is not visually detectable before use, healthcare professionals and patients remain unaware of the risk. Given the widespread use of such syringes in general healthcare settings, including immunization programs and vulnerable populations, the risk is categorized as HIGH, and immediate market withdrawal and user alert are necessary to protect public health.
                Action Initiated– The field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches 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 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).

                    Ahsan Hafiz Recall Alerts

                    Recall Alert

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                    DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

                    DRAP Alert NoNo I/S/09-25-79
                    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.