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17. Volunatry Recall. Osilex-D (Glitz Pharma)

Salateen Philip Recall Alerts

Recall Alert

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VOLUNTARY RECALL OF DRUG PRODUCT
DRAP Alert NoNo II/V/03-26-14
Action Date11 March, 2026.
Target Audience– National Regulatory Field Force.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue M/s Glitz Pharma, 205, Muhammadi Plaza, College Road, Rawalpindi – Pakistan (Plant: Plot No. 265, Industrial Triangle Kahuta Road, Islamabad) has informed the Drug Regulatory Authority of Pakistan (DRAP) regarding voluntary recall of the following drug product due to quality defect observed during ongoing stability studies.

Therapeutic Goods (s) Affected: –

S#Product NameBatchManufacturersMfg. & exp. date
1.Osilex D
Manufacturing Date:
August 2025

Expiry Date:
July 2027.  		T22125M/s Glitz Pharma
Plot No 265 Industrial Triangle Kahuta Road Islamabad.
(DML # 000571)		The firm has initiated recall of the above-mentioned batch after observing changes in physical appearance during stability studies which do not comply with approved quality specifications.
Risk Statement:The affected batch of Osilex D Tablet exhibited changes in physical appearance during stability studies. Although no adverse event has been reported, deviation from approved quality specifications may potentially compromise product quality, safety, and efficacy. The recall is being conducted as a precautionary measure to safeguard public health and ensure regulatory compliance.
Action InitiatedThe 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.
Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse
Event Reporting Form or online through this link.  Further information of reporting problems to DRAP is available on this link.
Advice for Pharmacies/Medical stores: –All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s).
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.

    16. Recall Alert (Human) – CDL Karachi declared substandard products.

    Salateen Philip Recall Alerts

    Recall Alert

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    DRUG PRODUCT DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.
    DRAP Alert NoNo II/S/03-26-14
    Action Date11 March, 2026.
    Target Audience– National Regulatory Field Force.
    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
    – General Public
    Problem / Issue Central Drugs Laboratory Karachi informed that the samples of below mentioned drug product has been declared as ‘Substandard’.

    Therapeutic Goods (s) Affected: –

    S#Product NameBatchManufacturersRemarks
    1.Santochlor ophthalmic Solution Chloramphenicol 5mg/ml (Reg # 021605)D-330M/s Sante (Pvt) Ltd. A/97 S.I.T.E Super Highway Karachi. (DML # 000702)The sample has been declared “substandard” on the basis of assay test.
    2.Ciprozat Tablet Ciprofloxacin 500mg/ per tablet (Reg # 031221)2421M/s Hizat Pharmaceutical Industry. 170 Industrial Estate Jamrud Road Peshawar. (DML # 000315)The sample has been declared “substandard” on the basis of dissolution test.
    Risk Statement:The above-mentioned batches of Santochlor Ophthalmic Solution (Chloramphenicol 5mg/ml) and Ciprozat Tablet (Ciprofloxacin 500mg) have been declared Substandard based on failure of assay and dissolution tests respectively.
    Substandard ophthalmic chloramphenicol may result in inadequate treatment of bacterial eye infections, leading to prolonged infection, worsening inflammation, or potential complications affecting vision. Substandard ciprofloxacin tablets may cause reduced therapeutic response in bacterial infections, increasing the risk of treatment failure, antimicrobial resistance, and disease progression.
    The most likely affected population includes patients suffering from eye infections and individuals being treated for bacterial infections, particularly those requiring timely and effective antibiotic therapy. Healthcare professionals are advised to discontinue use of the affected batches and ensure availability of quality-assured alternatives.
    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.

      15. Recall Alert (Veterinary) – DTLs Punjab declared substandard products.

      Salateen Philip Recall Alerts

      Recall Alert

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      VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

      DRAP Alert NoNo I/S/03-26-15
      Action Date11 March, 2026.
      Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
      ·         Healthcare Professionals-Veterinarians
      ·         Farmers/consumers
      Problem / Issue Provincial Drug Testing Laboratories, Punjab informed that the sample of below mentioned Veterinary Drug products have been declared as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      S#Product DetailsBatchManufacturer detailsRemarks
      1Injection Micrise-1% 10 ml
      Each ml contains:
      Ivermectin …. 10 mg
      (Reg # 111206)      		MR-087M/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 Testfor related substances.
      2.Injection Wormec 1% 10 ml
      Each ml contains:
      Ivermectin …. 10 mg (Reg # 020802)
      V00845      		M/s Nawan Laboratories (Pvt) Ltd. 
      136 Sector 15 Korangi Industrial Area Karachi.
      (DML # 000442)      		The sample is declared as “Sub-Standard” on the basis of Assay Test and Chromatographic Purity Test.
      Risk Statement:The above-mentioned batches of Ivermectin Injection 1% (10 ml) have been declared Sub-Standard based on failure of Assay and Chromatographic Purity tests, indicating possible incorrect potency and/or presence of unacceptable impurities.
      Substandard veterinary ivermectin may lead to treatment failure in parasitic infections, persistent worm burden, development of drug resistance, and potential toxicity in animals. The most likely affected population includes livestock (cattle, sheep, goats) and other animals treated for internal and external parasites, particularly in farm settings where mass deworming is practiced.
      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 and livestock owners are advised to immediately stop using the affected batch and isolate all remaining stock. Closely monitor treated animals for fever, swelling at the injection site, reduced appetite, or any sudden illness, and consult a veterinarian if such symptoms appear. Until animals are clinically stable, avoid selling or using milk or meat from visibly unwell animals. The affected product should be returned to the supplier or distributor according to recall instructions. Farmers are further advised to maintain proper records of batch numbers, treatment dates, and suppliers for traceability, and to ensure that only sterile, approved veterinary injections are used and stored under recommended conditions.

        14. Recall Alert (Human) – DTLs Punjab Declared substandard drug products.

        Salateen Philip Recall Alerts

        Recall Alert

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        DRUG PRODUCT DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES, PUNJAB.
        DRAP Alert NoNo II/S/03-26-14
        Action Date11 March, 2026.
        Target Audience– National Regulatory Field Force.
        – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
        – General Public
        Problem / Issue Drug Testing Laboratories of Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard ’.

        Therapeutic Goods (s) Affected: –

        S#Product NameBatch No.ManufacturersRemarks
        1.Medizole Suspension 60m1
        Each 5 ml contains
        metronidazole….40 mg
        Furazolidone….25 mg  
        (Reg # 005721)          		SR260004M/s Medicon Pharmaceutical Industries (Pvt) Ltd. 
        11 Industrial Estate Hayatabad Peshawar
        (DML # 000215)        		The sample is “Substandard” on the basis of pH test performed.
        2.Sachet PURGO 4mg
        Each sachet contains:
        Montelukast Sodium eq. to
        Montelukast …….4mg
        (Reg # 076497)          		055M/s Hiranis Pharmaceuticals (Pvt) Ltd. 
        Plot No. E-145 to E-149 North Western Industrial Zone Port Qasim, Karachi.        		The sample is “Substandard” on the basis of impurities test.
        3.Sachet G-Mont
        Each sachet contains:
        Montelukast Sodium eq. to Montelukast …….4mg
        (Reg #  080691)        		GMT108M/s GT Pharma (Pvt) Ltd.
        713 Sundar Industrial Estate Lahore.
        (DML # 000829)        		The sample is “Substandard” on the basis of impurities test.
        Risk Statement:The above-mentioned products have been declared Substandard based on laboratory testing (pH and impurities failure). Substandard medicines may result in reduced therapeutic effectiveness, delayed recovery, or unexpected adverse reactions.
        Children suffering from diarrhea and gastrointestinal infections (Medizole Suspension) and pediatric patients using Montelukast sachets for asthma or allergic conditions are most likely to be affected. Treatment failure in these populations may lead to worsening of symptoms, increased risk of complications, and unnecessary escalation of therapy.
        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.

          08. Recall Alert (Class-II) – DTLs punjab declared substandard drug products.

          Salateen Philip Recall Alerts

          Recall Alert

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          DRUG PRODUCT DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES, PUNJAB.
          DRAP Alert NoNo II/S/03-26-08
          Action Date11 March, 2026.
          Target Audience– National Regulatory Field Force.
          – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
          – General Public
          Problem / Issue Drug Testing Laboratories of Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard ’.

          Therapeutic Goods (s) Affected: –

          S#Product NameBatch No.ManufacturersRemarks
          1.Tablet Sapizine 10 mg  Each Tablet Contains: Cetrizine Dihydrochloride 10mg (Reg # 054261)13208M/s Sapient Pharma. 123-S Industrial Area Kot Lakhpat Lahore. (DML # 000207)The sample has been declared “substandard” on the basis of organic impurities.
          Risk Statement:Tablet Sapizine 10 mg (Cetirizine Dihydrochloride 10 mg) has been declared sub-standard due to the presence of organic impurities beyond acceptable pharmacopeial limits. Elevated organic impurities may indicate degradation, poor manufacturing control, or inadequate storage conditions, potentially leading to reduced potency, altered pharmacological effect, or increased risk of adverse reactions such as hypersensitivity or gastrointestinal disturbances.
          The population most likely to be affected includes general out-patient users, particularly children, elderly patients, and individuals with allergic rhinitis, urticaria, or other hypersensitivity conditions relying on consistent antihistaminic therapy. Although cetirizine is not a life-saving drug, compromised quality may result in therapeutic failure and unnecessary exposure to impurities.
          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.

            07. Recall Alert (Human) – DTLs Punjab declared substandard drug products.

            Salateen Philip Recall Alerts

            Recall Alert

            Download
            DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.  
            DRAP Alert NoNo I/S/03-26-07
            Action Date11 March, 2026.
            Target Audience– National Regulatory Field Force.
            – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
            – General Public
            Problem / Issue Drug Testing Laboratories of Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard & Adulterated’.

            Therapeutic Goods (s) Affected: –

            S#Product NameBatch No.ManufacturersRemarks
            1.Injection SORIDE Each mL contains: Sodium Chloride USP….9mg (Reg # 044017)SR260004M/s Bosch Pharmaceuticals (Pvt) Ltd. 221 Bosch House Sector 23 Korangi industrial Area Karachi.  (DML # 000350)The sample is declared as “Misbranded” under Section 3(s)(iv) of the Drugs Act, 1976 due to non-compliance with USP labelling requirements (osmolar concentration not stated on the label as required). The sample is also declared “Sub-Standard” on the basis of visible particulates in injection.
            2.Injection Neudex Each ml contains: Dexamethasone sodium phosphate eq. to dexamethasone phosphate……4mg (Reg #  042943)DX030M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576)The above sample is Adulterated as per The Drugs Act 1976, 3 (a)(iv) on the basis of Identification and Quantification of Dexamethasone (base).  
            Risk Statement:The cited products, Injection SORIDE (Sodium Chloride 0.9%) and Injection Neudex (Dexamethasone Sodium Phosphate 4 mg/mL), present significant clinical and regulatory risk. SORIDE has been declared misbranded due to non-compliance with USP labeling requirements (absence of osmolar concentration), which may lead to improper clinical use in sensitive populations such as neonates, critically ill, or electrolyte-imbalanced patients. More critically, the presence of visible particulates in a parenteral preparation classifies it as sub-standard, posing a direct risk of embolism, phlebitis, pyrogenic reactions, and systemic inflammatory responses.
            Injection Neudex has been declared adulterated based on failure in identification and quantification of dexamethasone (base), indicating potential presence of incorrect strength, substitution, or degradation. This may result in therapeutic failure in emergency conditions such as anaphylaxis, cerebral edema, severe asthma, or shock, where corticosteroids are life-saving.
            The population most likely to be affected includes hospitalized patients, emergency cases, pediatric and ICU patients receiving IV fluids or corticosteroid injections. The overall risk level is assessed as high, particularly because both products are injectable formulations administered systemically, and any quality defect may result in immediate and serious patient harm.
            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.

              06. Recall Alert (Veterinary) – DTLs punjab declared substandard products.

              Salateen Philip Recall Alerts

              Recall Alert

              Download

              VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

              DRAP Alert NoNo I/S/03-26-06
              Action Date11 March, 2026.
              Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
              ·         Healthcare Professionals-Veterinarians
              ·         Farmers/consumers
              Problem / Issue Drug Testing Laboratories, Punjab informed that the sample of below mentioned Veterinary Drug products have been declared as ‘Substandard’.

              Therapeutic Goods (s) Affected: –

              S#Product DetailsBatchManufacturer detailsRemarks
              1Injection. Penbiotic. Each vial contains: Benzyl Penicillin 500,000 I.U. Procaine Penicillin 1,500,000 I.U. Streptomycin Sulphate 5GM (Reg # 022148)  V02856M/s Nawans Laboratories (Pvt) Ltd. 136 Sector 15 Korangi Industrial Area Karachi.  (DML # 000442)The sample is Sub-Standard with regards to Assay andSterility  Test for related substances.
              2.Injection Ivovectin 2% Each ml contains: Ivermectin …. 20 mg (Reg # 079289)2523216M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)Declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
              3.Injection CYANORAS Each ml contains: Cyanocobalamin …. 25 mcg (Reg. # 109953)CYN-009M/s Ras Pharmaceuticals (Pvt) Ltd. 25-Km Lahore Road Multan. (DML # 000821)Declared as “Sub-Standard” on the basis of Assay test and Bacterial Endotoxins Test.
              4.Injection Ivergen 1% 50ml Each ml contains: Ivermectin …… 10 mg (Reg # 023432)605.IVM/s Symans Pharmaceuticals (Pvt.) Ltd. 10-Km Sheikhupura Road Lahore. (DML # 000323)Declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
              5.Injection Ivozon 1% Each ml contains: Ivermectin …… 10 mg (Reg # 119702)AP/RCB-024M/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.
              6.Injection. SUPERMEC 10ML Each ml contains: Ivermectin …… 10 mg (Reg # 075601)5773M/s Mylabs (Pvt) Ltd.  Khanka Sharif Tehsil and District Bahawalpur (DML # 000747)The sample is declared as “Sub-Standard” on the basis of Assay Test and Chromatographic Purity Test.
              7.Injection Ivotek Each ml contains: Ivermectin …… 10 mg (Reg # 016284)VM398M/s Star Laboratories (Pvt) Ltd.  23 Km Multan Road Lahore. (DML # 000130)Declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
              Risk Statement:The above-mentioned products, comprising parenteral veterinary and antimicrobial injections including Benzyl/Procaine Penicillin with Streptomycin, Ivermectin (multiple brands), and Cyanocobalamin, have been declared sub-standard on critical quality parameters such as Sterility, Assay, Related Substances, Bacterial Endotoxins, and Chromatographic Purity. Failure in sterility and endotoxin testing (particularly for Penbiotic and CYANORAS injections) poses a serious and immediate risk of septicemia, pyrogenic reactions, and treatment failure, while assay deviations and related substance impurities in multiple ivermectin products may result in under-dosing, toxicity, antimicrobial resistance, or therapeutic inefficacy. The population most likely to be affected includes livestock animals (cattle, buffaloes, sheep, goats, and poultry) receiving these veterinary injections, with indirect risk to farmers, dairy/meat consumers, and the general public through potential antimicrobial resistance development and compromised food 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 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 and livestock owners are advised to immediately stop using the affected batch and isolate all remaining stock. Closely monitor treated animals for fever, swelling at the injection site, reduced appetite, or any sudden illness, and consult a veterinarian if such symptoms appear. Until animals are clinically stable, avoid selling or using milk or meat from visibly unwell animals. The affected product should be returned to the supplier or distributor according to recall instructions. Farmers are further advised to maintain proper records of batch numbers, treatment dates, and suppliers for traceability, and to ensure that only sterile, approved veterinary injections are used and stored under recommended conditions.

                05. Recall Alert (Class-I) – CDL declared substandard – Teczone Forte Injection

                Salateen Philip Recall Alerts

                Recall Alert

                Download

                DRUG PRODUCT DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

                DRAP Alert NoNo I/S/02-26-05
                Action Date25 February, 2026.
                Target Audience– National Regulatory Field Force.
                – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
                – General Public
                Problem / Issue Central Drug Laboratory (CDL) Karachi informed that the samples of below mentioned drug product has been declared as ‘Substandard’.

                Therapeutic Goods (s) Affected: –

                S#Product NameBatch No.ManufacturersRemarks
                1.Teczone Forte Powder for Injection Each vial contains: Cefoperazone (as Sodium) ……1gm. Sulbactum …………..1gm. (Reg # 045516)02M/s SPL Pharmaceuticals (Pvt) Ltd. Plot No.4 Phase-III Industrial Estate Hattar. (DML # 000605)The sample has been declared “substandard” on the basis of pH test of reconstituted powder for injection.
                Risk Statement:An abnormal pH may compromise drug stability, efficacy, and patient safety, potentially leading to reduced therapeutic effect, injection site irritation, phlebitis, or systemic adverse reactions. Hospitalized patients receiving intravenous antibiotic therapy, particularly those with severe infections (e.g., sepsis, pneumonia, intra-abdominal infections), immunocompromised individuals, elderly patients, and critically ill patients in ICU settings, as this product is administered parenterally in institutional healthcare facilities.
                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.

                  03. Recall Alert (Class-I) – Veterinary Drug Products reports from DTLs Punjab.

                  Salateen Philip Recall Alerts

                  Recall Alert

                  Download

                  VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

                  DRAP Alert NoNo I/S/02-26-03
                  Action Date12 February, 2026.
                  Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
                  ·         Healthcare Professionals-Veterinarians
                  ·         Farmers/consumers
                  Problem / Issue Drug Testing Laboratories, Punjab informed that the sample of below mentioned Veterinary Drug products have been declared as ‘Substandard’.

                  Therapeutic Goods (s) Affected: –

                  S#Product DetailsBatch #Manufacturer detailsRemarks
                  1Injection. I-PENRIT-5 Each vial contains Procaine Penicillin…..1500000 iu, Benzyl Penicillin……500000 iu, Streptomycin Sulphate….5 gm (Reg # 079517)AM-164M/s International Pharma Labs. Raiwind Road Bhobtian Chowk Defence Road 1-Km Toward Kahna, Lahore. (DML # 000582)The sample is Sub-Standard with regards to Sterility Test .
                  2Duralin 50 Injection OXYTETRACYCLINE ……..50MG/ml (Reg # 078206)5782M/s Mylabs (Pvt) Ltd. Khanka Sharif Tehsil and District Bahawalpur. (DML # 000747)The sample is Misbranded with regards to labelling as defined under Section 3(s)(iv) of the Drugs Act,1976 and Substandard on the basis of Sterility Test.  
                  3.Ivotek Injection Ivermectin 10 mg/ml (Reg # 016284)VM583M/s Star Laboratories (Pvt) Ltd. 23 Km Multan Road Lahore. (DML # 000130)The sample is Sub-Standard with regards to Related substance.
                  4.Oxytovetz injection 50 ml Oxytocin 10IU/ML25129681M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)The sample is Sub-Standard with regards to Sterility Test & Assay test .
                  Risk Statement:These veterinary medicines present a moderate to high risk, primarily affecting livestock health and indirectly the general public. Substandard sterile injectable antibiotics (Penicillin/Streptomycin and Oxytetracycline) failing sterility tests may cause severe infections, abscess formation, treatment failure, and animal deaths, particularly in dairy cattle, poultry, and farm animals. Misbranding and quality defects can also lead to incorrect dosing and misuse by farmers and veterinarians. Substandard ivermectin with related substance issues may reduce effectiveness against parasites and increase the risk of drug resistance. Oxytocin injection failing sterility and assay tests is of serious concern as it is used during animal delivery and milk production, potentially causing reproductive complications and economic loss. The most likely to be affected are farmers, veterinarians, dairy producers, and consumers, due to possible consequences such as reduced food safety, antibiotic residues in milk/meat, and public exposure through the food 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 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 and livestock owners are advised to immediately stop using the affected batch and isolate all remaining stock. Closely monitor treated animals for fever, swelling at the injection site, reduced appetite, or any sudden illness, and consult a veterinarian if such symptoms appear. Until animals are clinically stable, avoid selling or using milk or meat from visibly unwell animals. The affected product should be returned to the supplier or distributor according to recall instructions. Farmers are further advised to maintain proper records of batch numbers, treatment dates, and suppliers for traceability, and to ensure that only sterile, approved veterinary injections are used and stored under recommended conditions.

                    02. Recall Alert (Class-II) – Drug Products tested by DTL Punjab

                    Salateen Philip Recall Alerts

                    Recall Alert

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                    DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.  
                    DRAP Alert NoNo II/S/02-26-02
                    Action Date12 Febraury, 2025.
                    Target Audience– National Regulatory Field Force.
                    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
                    – General Public
                    Problem / Issue Drug Testing Laboratories of Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard & Adulterated’.

                    Therapeutic Goods (s) Affected: –

                    S#Product NameBatch No.ManufacturersRemarks
                    1.TABLET ASCARD-75 Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin) 75mg (Reg # 016600)AR065L, AR047LM/s Atco Laboratories Limited. B-18 S.I.T.E Karachi. (DML # 000188)The sample has been declared “Substandard” with respect to test performed for “Related Substances”
                    2.Tablet Daisy 10 mg Each film coated tablet contains: Cetirizine dihydrochloride USP 10mg (Reg # 032865)  24F213M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore (DML # 000537)The sample has been declared “Sub-Standard” with regards to Impurities Tests.
                    3.Tablet Sapizine 10 mg Each Tablet Contains: Cetrizine Dihydrochloride 10mg (Reg # 054261)  13098M/s Sapient Pharma.  123-S Industrial Area Kot Lakhpat Lahore. (DML # 000207)The sample has been declared “Sub-Standard” with regards to Impurities Tests.
                    4.Tablet Rozen 10mg Each Tablet Contains: Cetrizine Dihydrochloride 10mg (Reg # 040161)5F006M/s Rasco Pharma (Pvt) Ltd.  5.5 Km Raiwind Road Ali Razabad, Lahore. (DML # 000530)The sample has been declared “Sub-Standard” with regards to Impurities Tests.
                    5.Cream Kanadex-N Each gram contains: Dexamethasone-21 phosphate in the form of disodium salt 1mg Neomycin in the form of sulphate 3500I.U (Reg # 012475)17-54, C8-26M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126)The sample is declared “Substandard” on the basis of the assay of Dexamethasone Phosphate (as disodium salt), and “Adulterated” on the basis of the identification and quantification of Dexamethasone (base) in HPLC analysis (which is an undeclared active pharmaceutical ingredient not stated on the product label.
                    Risk Statement:These products present a moderate to high public health risk, mainly affecting the general outpatient population, especially cardiac patients, allergy sufferers, children, and chronic medicine users. Substandard aspirin (Ascard-75) with excessive related substances may increase the risk of gastrointestinal irritation, bleeding, or reduced cardiovascular protection in patients using it for long-term prevention of heart attack or stroke. Multiple cetirizine brands failing impurity tests could expose the public—particularly children and individuals with liver or kidney compromise to unexpected toxic effects or reduced safety margins, even though the medicine is generally used for minor allergic conditions. The highest concern is Kanadex-N cream, where adulteration with an undeclared corticosteroid base can lead to misuse, skin thinning, hormonal suppression, masking of infections, and serious harm in infants or prolonged users, making dermatology patients and self-medicating consumers the most likely to be affected.
                    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.