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Recall Alert: Recall of Substandard Folic Acid Tablet Batches (490, 612) Manufactured By M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi.Recall Alert:

Muhammad Ayub Naveed Uncategorized

Recall Alert

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DRAP Alert NoNo I/S/12-24-56
Action Date18th December, 2024.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
– General Public
Problem / Issue The Provincial Inspector of Drugs of various districts of Balochistan collected the samples of Folic acid Tablet and sent for test / analysis. The Drug Testing Laboratory, Quetta has declared following batches of Folic acid Tablet, manufactured by M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi, as of substandard quality based on uniformity of weight:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Tablet Folic Acid
Reg. No. 000859		Folic acid 5 mgBatch No. 490
Batch No. 612		M/s. Zafa Pharmaceutical Laboratories (Pvt.) Ltd. 4/1, A&B, Block-21, Federal “B” Industrial Area, Karachi-75950 
Risk Statement:Folic Acid Tablets not complying with the uniformity of weight specification could result in inconsistent dosages of the active pharmaceutical ingredient (API), potentially leading to reduced therapeutic efficacy or an increased risk of adverse effects in patients.
Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have 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 the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

–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: Substandard Dexyken 300 mg Tablet Batch No. Kf23006  Manufactured By M/s. Kanel Pharma, Plot 6, Street SS-3, Rawat Industrial Estate, IslamabadRecall Alert:

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    Recall Alert

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    DRAP Alert NoNo I/S/12-24-55
    Action Date12th December, 2024.
    Target Audience– National Regulatory Field Force.
    – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
    – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
    – General Public
    Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. KQ-9-24-000142 has declared the subject mentioned batch of product Dexyken 300mg tablet as of substandard quality. Details of CDL test report are as under:

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by
    Dexyken Tablet

    Reg# 075234    		Dexibuprofen 300 mgBatch no. KF23006
    Mfg date: 06/2023
    Expiry date:
    06/2025    		M/s. Kanel Pharma, Islamabad
    Risk Statement:Dexibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce inflammation and pain in conditions such as arthritis. The identified quality issue with these tablets may result in Reduced Efficacy, depending on the degree of substandard quality and the patient’s condition. Vulnerable populations, including elderly patients and those with existing gastrointestinal, cardiovascular, or renal conditions, may be at a higher risk.
    Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have 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 the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

    –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: Substandard Nocox Tablets Batch No. 8463 Manufactured by M/s. Alfalah Pharma (Pvt.) Ltd., 12-Km Lahore Road, Jamal Park, Sheikhupura

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      DRAP Alert NoNo I/S/12-24-54
      Action Date12th December, 2024.
      Target Audience– National Regulatory Field Force.
      – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
      – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
      – General Public
      Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. LHR-10-24-000007 has declared the subject mentioned batch of product Nocox tablet as of substandard quality. Details of CDL test report are as under

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by
      Nocox Tablet

      (Reg# 052499)      		Meloxicam 15mgBatch no. 8463
      Mfg date: 02/2024
      Expiry date:
      02/2026      		M/s. Alfalah Pharma (Pvt.) Ltd., 12-km Lahore Rd, Jamal Park, Sheikhupura
      Risk Statement:Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce inflammation and pain in conditions such as arthritis. The identified quality issue with these tablets may result in Reduced Efficacy, depending on the degree of substandard quality and the patient’s condition. Vulnerable populations, including elderly patients and those with existing gastrointestinal, cardiovascular, or renal conditions, may be at a higher risk.
      Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have 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 the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

      –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.

        Rapid Alert: Contaminated Propylene Glycol (Batch # YF01210911) Allegedly Manufactured by M/S. Dongying Hi-Tech Spring Chemical Industry Co. Ltd., China.

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        Rapid Alert

        DRAP Alert NoNo  I/S/12-24-52
        Action Date12th December, 2024
        Target Audience1. Regulatory Field Force.
        2. Therapeutic Goods industry
        3. Manufactures of Oral liquid preparations
        4. Healthcare professionals
        Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No. RM-10-24-000624 dated 19-11-2024 declared the sample of Propylene Glycol (Raw material) sent to CDL Karachi by a licensed pharmaceutical manufacturer in compliance to advisory issued by DRAP vide No. 03-41/2023-QC dated 01-12-2023. The supply chain of this raw material is still under investigation. Details of test/analysis report are given as under:

        The product identification details are as under: –

        Therapeutic Good Affected:-

        ProductBatch No*Mfg DateExp. DateManufacturer Name
        (as per label)        		Remarks
        Propylene Glycol
        (Raw material)        		YF0121091122-May-202321-May-2025M/s. Dongying Hi-Tech Spring Chemical Industry Co. Ltd., China.[The material found in the packaging with the label of this manufacturer, however product authenticity and supply chain integrity are under investigation and yet not confirmed.]The sample is declared substandard
        due to conatmination of Ethylene Glycol.

        Risk StatementDi-Ethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
        Action InitiatedThe Regulatory Field Force has directed to take increase surveillance for identification of above mentioned contaminated batch of Propylene Glycol in the market and is investigating the entire supply chain of this batch. The Regulatory Field Force has also been instructed to seize all oral preparations manufactured using the same batch of propylene glycol if found in the market.
        Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
         
        1.      Recall Products: If any batch was manufactured using the same lot of Propylene Glycol that has been identified as contaminated, all finished products from local and export markets should be recalled.
        2.      Hold Other Batches: All finished products manufactured from the same lot of propylene glycol should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain.
        3.      Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.
        4.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.
        5.      Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.

        Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
        Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres.

        -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

        -Please click here for further information on problem reporting to DRAP.
        Advice for ConsumersConsumers should stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and 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.

        Rapid Alert : Falsified Product Askinoren Gel (Azelaic Acid 15%) Purportedly Manufactured By M/s. Medshare Pharma Risalpur, Kpk

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        Rapid Alert

        DRAP Alert NoNo I/S/12-24-56
        Action Date10rd December, 2024
        Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
        ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
        ·        General Public
        Problem StatementThe firm M/s OBS Pharma (Pvt.) Limited, Karachi, has notified DRAP regarding the presence of falsified product “Askinoren Gel” in the market across Pakistan.  The primary packaging of the product shows no Batch number and Expiry date. Also, a different brand name Acnoren was mentioned under the heading of dosage. Moreover, there was no Urdu instruction and dosage required as per Labelling Rules, 1986. The details of the identified product are as under:

        S#Product NameCompositionBatch No.Manufactured by
        (as per label claim)        		Lab Test Results
        1Askinoren GelAzelaic Acid 15%)NilM/s Medshare Pharma, Plot No. 04, Special Industrial Zone (APO) Risalpur, KPK.Spurious
        Risk Statement:Azelaic acid is used for the treatment of skin pigmentation and acne. Falsified product may pose a significant threat to public health as the safety and efficacy of such products cannot be established.
        Action InitiatedThe Regulatory Field Force has been directed to take necessary action on the above-mentioned falsified product and is investigating the entire supply chain of this product. The Regulatory Field Force has also been instructed to seize identified falsified products if found on the market.
        Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available at this link.

        Any adverse events or quality problems experienced with the use of these products should be reported to the 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 ConsumerConsumers 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 these 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.

        Rapid Alert: Falsified Dayquil Kids (Vicks) Berry Cold & Cough + Mucus Purportedly Manufactured By M/S. Procter & Gamble, Cincinnati, OH 45202.

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        Rapid Alert

        DRAP Alert NoNo I/S/12-24-51
        Action Date03rd December, 2024
        Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
        ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
        ·        General Public
        Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No. KQ-7-24-000112 dated 15-10-2024 declared the sample of DayQuil Kids (Vicks) as unregistered (Falsified) Drug. The product contains Dextromethorphan HBr which is an allopathic drug, therefore, the said product must be registered with DRAP. The details of the product are as under:

        S#Product NameCompositionBatch No.Manufactured by
        (as per label claim)        		Lab Test Results
        1DayQuil Kids (Vicks) Berry Cold & Cough + MucusNil31254334L4Purported to be manufactured by M/S.PROCTER & GAMBLE, CINCINNATI, OH 45202Spurious
        Risk Statement:DayQuil Kids (Vicks) is a widely available over-the-counter (OTC) medication for cough and flu relief. However, its active ingredient, Dextromethorphan HBr, may pose potential health risks, necessitating regulatory oversight to ensure safe consumption.
        Action InitiatedThe Regulatory Field Force has been directed to take necessary action on the above-mentioned falsified product and is investigating the entire supply chain of this product. The Regulatory Field Force has also been instructed to seize identified falsified products if found on the market.
        Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available at this link.

        Any adverse events or quality problems experienced with the use of these products should be reported to the 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 ConsumerConsumers 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 these 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.

        Recall Alert: Recall Notices for 7 products Issued By Provincial Drug Testing Laboratories

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        DRAP Alert NoNo I/S/11-24-50
        Action Date29th November, 2024.
        Target Audience– National Regulatory Field Force.
        – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
        – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
        – General Public
        Problem / Issue TDDCP PV Lahore and Secretary PQCB Quetta has informed DRAP regarding recall of following batches of mentioned products:

        Therapeutic Good(s) Affected: –

        Sr.No.Product NamesCompositionManufactured byTest Results
        1.Infusion Zeesol-5 1000 mL

        Reg# 016611        		Dextrose Anhydrous 50 g/ 1000mLShazeb Pharmaceutical Industries Limited Hazara Trunk Road, Sarai Gadaee, District Haripur, K.P.K PakistanSubstandard on the basis of Bacterial Endotoxin
        2.Sterile Water for Injection 5 mL

        Reg# 062671        		Sterile Water for InjectionFynk Pharmaceuticals 19-KM. G.T. Road, Kalashah Kaku, LahoreSubstandard” on the basis of Visible Particulates in Injections
        3.Infusion Cyanoco (Vitamin B12) 100mL

        Reg# 041241        		Cyanocobalamin 500 mcg/2mLInternational Pharma Labs Raiwind Road Bhobatian Chowk, Defence Road, 1-KM, towards Kahna LahoreAdulterated
        4.Infusion Cyanoco Super 100mL

        Reg# 041242        		Cyanocobalamin 1000 mcg/2mLInternational Pharma Labs Raiwind Road Bhobatian Chowk, Defence Road, 1-KM, towards Kahna LahoreAdulterated
        5.Syrup Desora

        Reg# 055192        		Desloratadine 0.5mg/mLS.J. & G. Fazul Ellahie (PVT) Ltd., E-46, S.I.T.E., KarachiEthylene Glycol above the permissible limit
        6.Inj. Isanex

        Reg# 024657        		Sterile Powder of Ceftriaxone Sodium
        eq. to Ceftriaxone 1g/Vial        		Humayun International Pharma (PVT) LTD 20-km, Satiana Road, Faisalabad“Substandard” with regards to Sterility Test
        7.EmpLiMet XR tablet

        Reg# 121679        		Empaglifozin, Linagliptin, Metformic HClHorizon Healthcare (Pvt.) Ltd., Plot no. 33, sundar Industrial estate, LahoreSubstandard on the basis of Assay

        Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have 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 the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

        –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: Recall of 6 Batches of Neutrozole Infusion Manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore

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          Recall Alert

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          DRAP Alert NoNo I/S/11-24-51
          Action Date29th November, 2024.
          Target Audience– National Regulatory Field Force.
          – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
          – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
          – General Public
          Problem / Issue The Provincial Inspector of Drugs, Punjab collected the samples of Neutrozole Infusion from various districts of Punjab and sent for test / analysis. The Drugs Testing Laboratory, Multan has declared various batches the said product, manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore, as a Substandard product. The details of the case are as under:

          Therapeutic Good(s) Affected: –

          Product NamesCompositionBatch DetailsManufactured by
          Neutrozole Infusion 100ml
           
          Reg. No. 046878            		Metronidazole (500mg/100ml)Batch No. MZ023,
          MZ028,
          MZ010,
          MZ007,
          MZ006,
          MZ003          		M/s. Neutro Pharma (Pvt.) Ltd., 9.5 Km, Sheikhupura Road, Lahore-Pakistan.
          Risk Statement:Administration of products containing bacterial endotoxins through IV infusion may lead to complications, such venous thromboembolism, septic shock etc. which may have fatal consequences.
          Action Initiated-The manufacturer has been directed to immediately recall the defective batch of product from the market. The field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of the presence and removal of the mentioned batches from the market
          -The regulatory field force of DRAP and Provincial Drug Control departments have 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 the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

          –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.

            Rapid Alert: Crackdown Against Falsified/Illegal Products

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            Rapid Alert

            DRAP Alert NoNo I/S/11-24-45
            Action Date28th November, 2024
            Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
            ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
            ·        General Public
            Problem StatementDirectorate of Drugs Control (DDC) Punjab and Secretary PQCB Quetta have informed DRAP that samples of various products have been identified as spurious (falsified). Details of test reports are as under:

            S#Product NameCompositionBatch No.Manufactured by
            (as per label claim)            		Lab Test Results
            1
            Titan-1000 Injection

            Reg# 021743            		CeIftriaxone as Ceftriaxone Sodium 1000 mg/vial 22044Purported to be manufactured by Macter International Limited (as per label claim) F-216, S.I.T.E Karachi“Spurious” and “Substandard” with regards to Assay and Sterility test,
            Dyrone Film Coated Tablet

            Reg# 198069            		Dydrogesterone DR-121Purported to be manufactured by Solvay (as per label claim), Plot # 32, Sector,2 Highway Petaro Road Jamshoro SindhSpurious
            Solverone 10 mg Film Coated Tablet

            Reg# 068898            		DydrogesteroneSVN-001Purported to be manufactured by Solvay (Fictitious firm), Plot # 32, Sector,2 Highway Petaro Road Jamshoro SindhSpurious
            Dydowen 10mg Film Coated Tablet

            Reg# 101507            		Dydrogesterone736Purported to be manufactured by Weather Folds Pharmaceuticals, Hattar, Pakistan. Manufactured For: Wenovo Pharmaceuticals TaxilaSpurious
            DYDRO-FEM 10 mg Film CoatedTablet

            Reg# 555199            		DydrogesteroneDFD10/008
            DFD10/009            		Purported to be manufactured by
            Torrent Pharmaceutical, (as per label claim) G-19, Hawkesbay Road SITE, Karachi.            		Spurious
            M.CEF 30 mL Powder For Oral Suspension

            Reg# 0432189            		Cefixime as Trihydrate 100 mg/5mLD00018Purported to be manufactured by
            Dalton Laboratories PVT LTD. (as per label claim) Plot # G-149, Phase L-II Super Highway Road,
            S.I.T.E. LI Karachi            		Spurious
            Iodex Ointment

            Reg# 000394            		Iodine + MethylsalicylateHIAACPurported to be manufactured by GSK Pakistan KarachiCounterfeit
            (Falsified)
            Risk Statement:The impact of the use of falsified / Substandard products may lead to sub-optimal therapeutic effects whereas the use of a spurious product will lead to therapy failure or other associated problems.
            Action InitiatedThe field force under the administrative control of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for the detection of the presence and removal of the 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 this product. Further information on reporting problems to DRAP is available on this link.

            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 ConsumerConsumers 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 these 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.