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109. Recall Alert (Class-I) – Zayzine Syrup (Batch # 25289)

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Recall Alert

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DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

DRAP Alert NoNo I/S/11-25-109
Action Date17 November, 2025.
Target Audience– National Regulatory Field Force.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Central Drugs Laboratory informed that the sample of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#Product NameBatch No.ManufacturersRemarks
1.Zayzine Syrup Each 5 ml Contains:
Cetirizine Dihydrochloride … 5 mg (Reg # 096969)		25289M/s Zaynoon Pharmaceuticals (Pvt) Ltd.  27-28/B, Industrial Estate, Hayatabad, Peshawar (DML # 000358)The sample has been declared Substandard on the basis of the Assay Test and Physical Description, as the syrup was found to be a clear, colourless liquid in an amber plastic bottle, whereas the manufacturer’s specification describes it as a light green, translucent, viscous, and sugar-free preparation.
Risk Statement:As the product was found to contain excessive amount of the labeled active ingredient and to differ in appearance from the approved specifications. The excessive assay value indicates overdose of Cetirizine Dihydrochloride, which may cause drowsiness, dizziness, headache, or other antihistaminic side effects, particularly in children and sensitive individuals for whom this syrup is commonly prescribed. The defect therefore poses a potential risk to public health, especially in pediatric and allergic patients, and warrants a Class I recall of the affected batch to prevent further exposure 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.

    108. Recall Alert (Veterinary Drug Product) – Melovetz 10 Injection (Batch # 2599063)

    Salateen Philip Recall Alerts

    Recall Alert

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

    DRAP Alert NoNo I/S/11-25-108
    Action Date12 November, 2025.
    Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
    ·         Healthcare Professionals-Veterinarians
    ·         Farmers/consumers
    Problem / Issue Central Drugs Laboratory Karachi informed that the sample of below mentioned Veterinary product has been declared as ‘Substandard’.

    Therapeutic Goods (s) Affected: –

    S#Product DetailsBatch #Manufacturer detailsRemarks
    1.Melovetz 10 Injection  Each 100 ml Contains:
    Meloxicam (B.P) ……. 10mg (Reg # 102021)    		2599063M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)Sample is Sub-Standard on the basis “Sterility test”.
    Risk Statement:Use of a non-sterile injectable veterinary preparation may cause local abscesses, septicemia, or systemic infections in treated livestock, leading to reduced productivity, illness, or death in affected animals. Such contamination also poses an indirect public health risk through the potential presence of harmful microorganisms or residues in milk and meat intended for human consumption. Therefore, the affected batch poses a significant risk to animal and public health and requires immediate recall and segregation from all levels of the supply chain.
    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 the affected batch of Melovetz 10 Injection (Batch No. 2599063) on their animals. Use of a non-sterile veterinary injection may cause swelling, abscess formation, fever, or serious infection in treated livestock. If any animals have recently been injected with this product and show unusual signs of illness, weakness, or loss of appetite, discontinue use immediately and consult a qualified veterinarian.
    The remaining stock of the affected batch should be returned to the supplier, distributor, or local veterinary office. Farmers are further advised to purchase veterinary medicines only from authorized sources, ensure that the packaging carries valid registration and batch details, and always check the expiry date and product integrity before use. Proper recordkeeping of veterinary products and prompt reporting of any suspected quality issues to the Provincial Livestock Department or DRAP are strongly encouraged to protect animal and public health.

      107. Recall Alert – (Class-I) Injection Isobaj (Batch # IB-0925)

      Salateen Philip Recall Alerts

      Recall Alert

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      DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

      DRAP Alert NoNo I/S/11-25-107
      Action Date13 November, 2025.
      Target Audience– National Regulatory Field Force.
      – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
      – General Public
      Problem / Issue Central Drugs Laboratory informed that the sample of below mentioned drug product has been declared as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      S#Product NameBatch No.ManufacturersRemarks
      1.Isobaj Injection 10ml Each ml contains: Isosorbide Dinitrate ……. 1mg (Reg # 100721)IB-0925M/s Bajwa Pharmaceuticals (Pvt) Ltd. 36-Km Lahore Gujranwala Road Khori District Sheikhupura. (DML # 000805)Sample is Sub-Standard on the basis “Bacterial Endotoxin test”.
      Risk Statement:The sample of Isobaj Injection 10 mL (Batch No. IB-0925) has been declared “Substandard” on the basis of failure in the Bacterial Endotoxin Test, indicating the possible presence of pyrogenic contamination. Use of such injectable preparations may cause fever, chills, hypotension, or severe adverse reactions, particularly in hospitalized, cardiac, or elderly patients for whom this product is commonly prescribed. As the defect directly affects the safety and quality of the product, the batch poses a high public-health risk and warrants an immediate Class I recall, with retrieval of all distributed stock to prevent potential harm to patients.
      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.

        106.Recall Alert – (Class-III) Tablet Cekamol 500 mg (Batch # T-5014)

        Salateen Philip Recall Alerts

        Recall Alert

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        DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

        DRAP Alert NoNo III/S/10-25-106
        Action Date12 November, 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.Tablet Cekamol 500 mg Each Tablet Contains: Paracetamol ……. 500 mg (Reg. # 004268)T-5014M/s CKD Pharmaceuticals Pakistan (Pvt) Ltd. 50/28 Korangi Industrial Area Karachi. (DML # 000144)The sample is “Substandard” with respect to physical characteristics observed. (White colored, round shaped, flat tablet with bevelled edges, have score line on one side and other side is engraved with “CKD”, packed in ALU/PVC blister of 1*10’s. Mmanufacture Sspecification claims that tablet should be round, flat and plain from both sides.)
        Risk Statement:The sample of Tablet Cekamol 500 mg (Batch No. T-5014) has been declared “Substandard” with respect to its physical characteristics, as the tablets bear engraving and a score line inconsistent with the approved product specifications. Although this deviation does not affect the safety, strength, or efficacy of the medicine, it indicates non-compliance with Good Manufacturing Practices (GMP) and approved appearance standards. The defect poses no direct risk to patient health; however, recall of the affected batch is recommended to maintain product quality and regulatory compliance.s.
        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.