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

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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.

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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.

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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.

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        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.

          13. Rapid Alert – SPURIOUS TABLET D-GEST DYDROGESTERONE 10 mg) (BATCH NO. DGH007)

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          Rapid Alert

          SPURIOUS TABLET D-GEST DYDROGESTERONE 10 mg) (BATCH NO. DGH007)
          DRAP Alert NoNo I/S/03-26-13
          Action Date11 March, 2026
          Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
          2. Healthcare Professionals
          3. Pharmacies and medical stores
          Problem StatementDrug Testing Laboratory (DTL), Punjab vide Test Report No. 01-10096006005/DTL dated 21-02-2026 has declared Tablet D-Gest (Dydrogesterone 10 mg), labeled as manufactured by M/s Pharma Health Pakistan (Pvt.) Ltd., 17-Km Ferozepur Road, Lahore, as Spurious under Section 3(zb)(ii) of the Drugs Act, 1976, as laboratory analysis revealed that Dydrogesterone was not identified by FTIR and assay testing showed 0.0 mg per tablet against the labeled claim of 10 mg (specification limit 90–110%), indicating complete absence of the declared active pharmaceutical ingredient.
          S#Product NameBatchManufacturerTest Result
          1Tablet D-Gest (Dydrogesterone 10 mg)DGH007M/s Pharma Health Pakistan (Pvt) Ltd. 17-Km Ferozepur Road Lahore (DML # 000761)Declared Spurious (API absent)
          Risk StatementDydrogesterone is indicated for management of progesterone deficiency conditions including threatened miscarriage, menstrual disorders, and luteal phase support. Laboratory findings confirmed complete absence of the active ingredient, resulting in total therapeutic failure. Use of such product may lead to serious clinical consequences including pregnancy loss, hormonal imbalance, and failure of prescribed treatment. The public health risk is assessed as high, particularly in pregnant women and hormone-dependent patients.
          Action InitiatedThe Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
          Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to  National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
          Advice for ConsumersConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

          12. Rapid Alert – SPURIOUS CAPSULE GABICA 300 mg (BATCH NO. 518C27)

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          Rapid Alert

          SPURIOUS CAPSULE GABICA 300 mg (BATCH NO. 518C27)
          DRAP Alert NoNo I/S/03-26-12
          Action Date11 March, 2026
          Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
          2. Healthcare Professionals
          3. Pharmacies and medical stores
          Problem StatementDrug Testing Laboratory (DTL), Punjab vide Test Report No. 01-105013280/DTL dated 23-02-2026 has declared the following sample of product as Spurious under Section 3(zb)(ii) of the Drugs Act, 1976.
          The product is purported to be manufactured by M/s Getz Pharma (Pvt.) Limited, Karachi, Pakistan. However, the manufacturer has officially disowned the recovered sample and confirmed that the sealed sample has neither been manufactured nor sold by them. The firm has categorically declared the product counterfeit after physical comparison with their retention sample.
          S#Product NameBatchManufacturer (as per label)Test Result
          1Capsule Gabica 300 mg
          Each Capsule contains:
          Pregabalin 300 mg          		518C27Purported to be manufactured by
          M/s Getz Pharma (Pvt.) Limited,
          29-30/27, K.I.A., Karachi, Pakistan          		Declared Spurious
          Risk StatementGabica (Pregabalin) 300 mg is indicated for neuropathic pain, epilepsy, and generalized anxiety disorders. Although laboratory testing showed compliance in assay and dissolution parameters, the manufacturer has confirmed that the recovered batch is counterfeit and not produced or marketed by them. Use of falsified pregabalin capsules may result in therapeutic inconsistency, treatment failure, or exposure to unknown manufacturing conditions. The circulation of counterfeit medicines poses a significant public health concern due to lack of regulatory oversight and quality assurance.
          Action InitiatedThe Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
          Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to  National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
          Advice for ConsumersConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

          11. Rapid Alert – SPURIOUS & SUBSTANDARD INJECTION VENOFER 5 mL (Batch No. 4721026AA)

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          Rapid Alert

          SPURIOUS & SUBSTANDARD INJECTION VENOFER 5 mL (Batch No. 4721026AA)
          DRAP Alert NoNo I/S/03-26-11
          Action Date11 March, 2026
          Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
          2. Healthcare Professionals
          3. Pharmacies and medical stores
          Problem StatementDrug Testing Laboratory (DTL), Punjab has declared the following sample of product as Spurious under Section 3(zb)(ii), Misbranded under Section 3(s)(vi), and Substandard under the Drugs Act, 1976.
          S#Product NameBatch No.Manufacturer (as per label)Test Result
          1Injection Venofer 5 mL (Iron Sucrose 100 mg/5 mL)4721026AAPurported to be manufactured by Takeda Austria GmbH, Austria Imported by: M/s Searle Pakistan LimitedDeclared Spurious, Misbranded & Substandard (Assay failure of Iron & Sucrose)

          The product is purported to be manufactured by Takeda Austria GmbH, Austria and imported by M/s Searle Pakistan Limited. However, the authorized importer has officially disowned the recovered sample and confirmed, after physical comparison with their retention sample of the same batch, that the provided sample is counterfeit.

          Laboratory analysis revealed failure of assay for Iron and Sucrose contents, while sterility test complied. The product also does not contain finished drug product specifications.

          Risk StatementThe product is a Human Anti-D (Rh) Immunoglobulin injection indicated for prevention of Rh isoimmunization in Rh-negative individuals. Laboratory testing revealed microbial growth in sterility testing, indicating contamination and rendering the product unsafe for parenteral administration. Additionally, the batch has been confirmed as falsified and not legally imported by the authorized distributor. Administration of this contaminated and spurious biological product may lead to serious bloodstream infections, therapeutic failure in prevention of Rh sensitization, and life-threatening complications. The public health risk is assessed as high, particularly for pregnant women and immunocompromised patients.
          Action InitiatedThe Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
          Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to  National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
          Advice for ConsumersConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.