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RAPID ALERT – CRACKDOWN AGAINST UNLICENSED/UNAUTHORIZED MANUFACTURERS

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Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert NoNo I/S/08-25-54
Action Date11th August, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementThe Drug Regulatory Authority of Pakistan (DRAP) has received information from the Drug, Water and Food Testing Laboratory, Gilgit-Baltistan, indicating that the following purported drug products have been declared ‘spurious’ upon analysis and reportedly manufactured by entities not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#Product NameBatch No.Purported ManufacturerRemarks
1Missron Tablet   Each Tablet contains Dydrogesterone ……. 10mg  48022M/s Fegga Pharmaceutical, F-21/H.P.T.C., S.I.T.E., KARACHI.Drug Water and Food Testing Laboratory  Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
2Quttefol OD tablets   Each film coated tablet contains L-Methyl-Folate (Folic Acid) …………………… 800 mcg Vitamin B12 …….1000 mcgQL-001M/s Adcok Pharmaceuticals Factory 3-km Defense Road Off-Raiwind Road, LahoreDrug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as under: – For assay of Vitamin B12, ‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976 & For assay of Folic Acid,   ‘Substandard’  as defined under sub-section (zz) of Section 3 of the Drugs Act, 1976.
3Depasrone Tablets   Each Tablet contains Dydrogesterone ……. 10mg  2406M/s Alpine Laboratories, Plot A-41, S.I.T.E., KarachiDrug Water and Food Testing Laboratory  Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
4Dropha Tablets   Each Tablet contains Dydrogesterone ……. 10mg  DRP-0004M/s Himax Pharmaceutical, Plot # 445, Korangi Industrial Area, KarachiDrug Water and Food Testing Laboratory  Gilgit Baltistan declared the purported drug product as  ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
Risk StatementAll the above-mentioned purported drug products have been confirmed as falsified/spurious, as they are manufactured by entities that are neither licensed nor authorized by the Drug Regulatory Authority of Pakistan (DRAP). These products are being illegally manufactured and marketed without regulatory oversight, rendering their quality, safety, and efficacy highly doubtful. Laboratory testing has revealed the absence of active pharmaceutical ingredients in some samples, indicating a complete lack of therapeutic value. The circulation and use of such unregulated products pose a serious risk to public health, including treatment failure, disease progression, and potential life-threatening consequences. The public is strongly advised to avoid the use of these unregistered drug products and report any suspicious or unauthorized medicines to DRAP through its official reporting channels.
Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product.

All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
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.

VOLUNTARY RECALL ALERT – Amoxil Forte Suspension & Amoxil Suspension due to complaint of Induction Seal.

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DRAP Alert NoNo II/V/08-25-53
Action Date05th August 2025.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue M/s GlaxoSmithKline Pakistan Ltd., F-268, S.I.T.E., Karachi (DML No. 000233) has informed the Drug Regulatory Authority of Pakistan (DRAP) that the following drug products are being voluntarily recalled due to defective induction seal.

Therapeutic Goods (s) Affected: –

S#Product NameManufacturersBatch No.
1Amoxil Forte Suspension 250 mg
(Reg. # 006814)		M/s GlaxoSmithKline Pakistan Ltd. F-268 SITE Karachi
(DML # 000233)		7W9V, 7W9W, 7W9X, 8L5H, 8R3M, 8L5J, 8R4J, 8R4G, 8R3N, 8R4M, 8R4N, 8T5A, 9S5D, 9S5B, 9U6F, 9X3E, 9U6E, 9X3G, 9X3F, AH9Y, AJ2A, AP2M, AP2N, AP2P, AP2T, AS5B, AS5K, AS5F, AT7M, AS5L, C25W, C25X, C37E, C37G, C99F, C58B, CB4N, CB4P, CB4R, CD6T, CD6W, CD6V, DL5L, DL5K, DL5M, EE9R, EE9N, DY5U, EE9T, EG2A, FA8M, FA8N, FB9C, FB9D, FB9E, FB9F, FE9X, FF2A  
 2Amoxil Suspension 125 mg
(Reg. # 000508)		M/s GlaxoSmithKline Pakistan Ltd. F-268 SITE Karachi
(DML # 000233)		8U3B, 8T5G, 8T5L, 8U3A, 8U3G, 8U3H, 8W9S, 8W9T, 925W, 925Y, 926B, 926A, 956M, 956R, 966V, 967C, 967F, 967E, 988F, 988H, 988G, 9B4P, 988K, 9B4M, 9B4S, 9D6K, 9B4T, 9D6M, 9D6P, 9D6T, 9G4N, 9G4P, 9L9N, 9L9M, 9P7R, 9P7S, 9R2V, 9R2U, 9S4Y, 9S5A, AW3A, AW3B, AW3H, AW3D, AY5T, AY5X, AY5V, AY6B, B44T, B44M, B44S, BB2Y, B44V, BB3A, BB3B, BF3B, BF2X, BB3C, BF3C, BF3A, BT9H, BT9G, BT9F, BT9J, BW8R, BW8M, BW8S, BW8T, BX8L, BX8N, BX8P, CG4V, CG4X, CG4W, CG4Y, CJ7B, CJ6W, CJ7C, CJ7D, CP5G, CP5H, CT5X, CT6A, CW3H, CW3G, CY3A, D64P, D64S, CY3K, EP7E, EN4U, EN4T, EP7J, EP7M, EP7P, ET8M, EW3F, F55S, F32W, F55V, F55U, F55T, F97P, F75G, F75J, F75K, F75N, FT2Y, FU7X, FU7Y, FT3A
Risk Statement:These drug products are being voluntarily recalled by the manufacturer due to a quality defect related to the defective induction seal of bottles, which may potentially compromise product integrity. The undetected defect may pose risk under certain conditions of storage or use. This recall is being carried out as a precautionary measure in consultation with the Drug Regulatory Authority of Pakistan (DRAP) to safeguard public health.
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 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 – BATCHES OF ‘TABLET FAMILA 28F’ DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

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    DRAP Alert NoNo II/S/08-25-52
    Action Date04 August, 2025.
    Target Audience– National Regulatory Field Force.
    – Pharmacists and Chemists     in Distribution, Pharmacies and Medical Stores
    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
    – General Public
    Problem / Issue Central Drugs Laboratory Karachi informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug product has been declared as ‘Substandard’.

    Therapeutic Goods (s) Affected: –

    Product Details: Famila 28F Tablets (Reg. # 023941)

    Manufactured by: M/s Zafa Pharmaceuticals Lab (Pvt) Ltd.  (DML # 000490)

    Batch No.CDL Test Result / Remarks
    K217‘Substandard’ on the basis of tests (Content uniformity of Levonorgestrel & Ethinyl Estradiol. Weight variation of Ferrous Iron).
    K177‘Substandard’ on the basis of tests (Content uniformity of Levonorgestrel & Ethinyl Estradiol. Weight variation of Ferrous Iron. Assay test of Levonorgestrel.)
    K203, K207‘Substandard’ on the basis of test of weight variation of Ferrous Iron.
    K184, K190, K191‘Substandard’ on the basis of tests of Content uniformity of Levonorgestrel & Ethinyl Estradiol. Assay test of Levonorgestrel.
    K182‘Substandard’ on the basis of tests of Content uniformity of Levonorgestrel & Ethinyl Estradiol. Weight variation of Ferrous Iron.
    K199, K205‘Substandard’ on the basis of tests Content uniformity of Ethinyl Estradiol & Weight variation of Ferrous Iron.
    K204‘Substandard’ on the basis of test of Content uniformity of Levonorgestrel & Ethinyl Estradiol.
    Risk Statement:The affected batches of Famila 28F Tablets due to content uniformity, assay failures of hormonal ingredients, and weight variation in the iron component, may lead to reduced contraceptive efficacy, hormonal imbalance, and inconsistent iron supplementation.
    Use of such products can cause therapy failure and complications.
    Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market.

    – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company.

    –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk.

    –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
    Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

    -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the     Adverse Event Reporting Form or online through this link.

    -Please click here for further information on problem reporting to DRAP.
    Advice for Consumers-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

    -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

      Recall Alert – MEDICAL DEVICES DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

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      DRAP Alert NoNo I/S/07-25-51
      Action Date29 July, 2025.
      Target Audience– National Regulatory Field Force.
      – Pharmacists and Chemists       in Distribution, Pharmacies and Medical Stores
      – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
      – General Public
      Problem / Issue Central Drugs Laboratory Karachi informed Drug Regulatory Authority of Pakistan that the samples of below mentioned Medical Devices have been reported as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      Product NamesBatch DetailsManufactured byTest Results
      ZINDAGI Auto Disable Syringe 5ml
      (MDMR-000117)      		5-01E-25M/s Al-Badar Manufacturing (Pvt.) Ltd. Gadoon Amazai KPK (ELM-0029)‘Substandard’ on the basis of Sterility Test.
      Ultra Fine SMD Painless Syringe 5ml
      (MDMR-000229)      		5053CEM/s Sehat Medical Device (Pvt.) Ltd, Lahore. (ELM-0065) ‘Substandard’ on the basis of Sterility Test & description test (The clear visible black particles found in the barrel of syringe).
      Ultra Fine SMD Painless Syringe 3ml
      (MDMR-000229)      		3022CDM/s Sehat Medical Device (Pvt.) Ltd, Lahore. (ELM-0065) ‘Substandard’ on the basis of Sterility Test & description test (The clear visible black particles found in the barrel of syringe).
      Risk Statement:Use of substandard syringes, in invasive or intravenous procedures, poses a significant risk of introducing microbial contaminants into the patient’s body, which may result in localized infections, abscesses, or life-threatening systemic infections, particularly in immunocompromised individuals.
      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 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: PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

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        DRAP Alert NoNo I/S/06-25-50
        Action Date23rd June, 2025.
        Target Audience– National Regulatory Field Force.
        – Pharmacists and Chemists         in Distribution, Pharmacies and Medical Stores
        – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
        – General Public
        Problem / Issue The Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

        Therapeutic Goods (s) Affected: –

        Product NamesCompositionBatch DetailsManufactured byTest Results
        Medistil Injection

         
        Reg. No. 064758        		Sterile Water for Injection……5ml25L608M/s. Medisave Pharmaceuticals,
        578-579, Sundar Industrial Estate, Lahore.         		‘Substandard’ on the basis of Bacterial Endotoxin Test.
        Kanadex-N Cream

         
        Reg. No. 012475        		Each gram contains:
        Dexamethasone-21 phosphate as disodium salt…….1mg
        Neomycin as sulphate…3500 i.u.        		F7-27M/s ISIS Pharmaceuticals & Chemical Works,
        25/1-3, Sector 12-C, North Karachi Industrial Area, Karachi.          		‘Substandard’ on the basis of Assay of Dexamethasone phosphate.
        Bytec Tablet 10mg

         
        Reg. No. 036183        		Each Film coated tablet contains:
        Cetirzine dihydrochloride…..10mg        		E090M/s Batala Pharmaceuticals.,
        23/B Small Industrial Estate #2, Gujranwala.         		‘Substandard’ on the basis of Impurities test.
        Sterile Water for Injection 5ml


        Reg. No. 071329        		Sterile Water for Injection….5ml25WF01M/s Friends Pharma (Pvt) Ltd.,
         31-Km, Ferozpur Road, Lahore.        		‘Substandard’ with regards to visible particulates in injection.
        Cetfin 10mg Tablet

        Reg. No. 091843        		Each film coated tablet contains:
        Cetirizine dihydrochloride ..…..10mg        		CT67M/s. Effort Pharmaceuticals (Pvt.) Ltd,
        28-Km, Ferozpur Road, Lahore.         		‘Substandard’ on the basis of Test for impurities (Organic impurities).
        Kanabax Cream 15g

        Reg. No. 070880        		Each gram contains:
        Dexamethasone….1mg
        Neomycin Sulphate….3.5mg        		KNX-270M/s. Baxter Pharmaceuticals,
        A-1/A, Phase 1, S.I.T.E., Super Highway, Karachi.          		‘Misbranded’ with regards to Labeling as per Section 3(s)(iv), ‘Adulterated’ with regards to Section 3(a)(iv) of Drugs Act, 1976, and ‘Substandard’ on the basis of Assay of Neomycin and Dexamethasone Phosphate.
        Surgitex Latex Surgical Gloves (powdered)

        Reg. No. MDIR-0001236        		Surgitex Latex Surgical Gloves Size 7.0 Powdered Sterile20241001Manufactured by:
        Suzhou Colour-way New Material Co., Ltd, 20 Anmin Road, Huangdai Town, Xiangcheng District 215152, Suzhou, China.
         
        Marketed by:
        M/s Al-Hamd Enterprises FL-11/1/1, Block-6, Gulshan-e Iqbal, Karachi.         		‘Substandard’ with regards to Sterility Test.
        Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
        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 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 Substandard “Famobex Suspension” Batch No. 5330, Manufactured by M/s Cibex (Pvt.) Ltd, Karachi.

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          DRAP Alert NoNo I/S/06-25-49
          Action Date23rd June, 2025.
          Target Audience– National Regulatory Field Force.
          – Pharmacists and Chemists           in Distribution, Pharmacies and Medical Stores
          – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
          – General Public
          Problem / Issue Federal Government Analyst, CDL, Karachi vide test report No. KQ-2-25-000015 has declared the sample of subject mentioned batch of the product as of ‘Substandard’ quality. Details of the CDL test report are as under:

          Therapeutic Goods (s) Affected: –

          Product NamesCompositionBatch DetailsManufactured byTest Results
          Famobex Suspension

           
          Reg. No. 027108          		Each 5ml contains:
          Famotidine.……10mg          		5330M/s Cibex (Private) Limited.,
          F-405, S.I.T.E, Karachi.          		‘Substandard’ on the basis of Assay test.
          Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
          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 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 PRODUCTS CONTAINING HYDROXYPROGESTERONE CAPROATE

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            DRAP Alert NoNo I/S/06-25-48
            Action Date16th June, 2025.
            Target Audience– National Regulatory Field Force.
            – Pharmacists and Chemists             in Distribution, Pharmacies and Medical Stores
            – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
            – General Public
            Problem / Issue The Registration Board, in its 346th meeting held on 22nd April 2025, decided to ‘suspend’ registrations of products containing 17-Hydroxyprogesterone caproate, in light of the decision made by the Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) of the European Medicine Agency (EMA). The details of the marketing authorization holders of the said molecule are provided below: 

            Therapeutic Goods (s) Affected: –

            Product NamesCompositionManufactured by
            GLOBINAN INJECTION 1ML & 2ML

             
            Reg. No. 030525 & 030526            		Each ampoule contains:
            Hydroxyprogesterone caproate …..250mg            		M/s Global Pharmaceuticals (Pvt.) Ltd.,
            Plot No. 204-205, Industrial Triangle Kahuta Road, Islamabad.
            HYDROXYPROGESTERONE INJECTION

             
            Reg. No. 003746            		Each ampoule contains:
            Hydroxyprogesterone caproate …..250mg            		M/s Haji Medicines Co,
            Haji Yasin Block, Plot No. 206& 207, Industrial Triangle, Kahuta Road, Islamabad  
            NANDROSOL 250MG INJECTION

             
            Reg. No. 096479            		Each ampoule contains:
            Hydroxyprogesterone caproate …..250mg            		M/s. Pharmasol (Pvt.) Ltd.,
            Plot No. 549, Sundar Industrial Estate, Lahore.  
            HYGEST INJECTION


            Reg. No. 094205            		Each ampoule contains:
            Hydroxyprogesterone caproate …..250mg            		M/s Shaigan Pharmaceuticals (Pvt.) Ltd,
            l4 Km, Adyala Road Post Office Daghal, Rawalpindi.
            VIO-DEPOT INJECTION

            Reg. No. 013624            		Each ampoule contains:
            Hydroxyprogesterone caproate …..250mg            		M/s. Venus Pharma,
            23Km Multan Road Lahore,
            Lahore. 
            HYDROXYPROGESTERONE INJECTION

            Reg. No. 003531            		Each ampoule contains:
            Hydroxyprogesterone caproate …..250mg            		M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd.,
            L-4/1, A&8, Block 21, F.B Industrial Area, Karachi.
            Risk Statement:A review by EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC) concluded that there is a possible but unconfirmed risk of cancer in people exposed to 17-Hydroxyprogesterone Caproate in the womb. In addition, the review considered new studies which showed that the said product is not effective in preventing premature birth; there are also limited data on its effectiveness in other authorized uses.
            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 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 / SPURIOUS DRUGS

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              Rapid Alert

              DRAP Alert NoNo  I/S/06-25-47
              Action Date13th June, 2025
              Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
              2. Healthcare Professionals
              3. Pharmacies and medical stores
              Problem StatementThe Directorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’. The details of the report are as under:

              The product identification details are as under: –

              Therapeutic Good Affected:-

              Product Batch No Manufacturer Name
              (as per label)               		Remarks
              Klaricid Tablet 500mg
               
              Each film coated contains:
              Clarithromycin……500mg              		722269XVM/s Abbott Laboratories (Pakistan) Ltd.,
              Landhi, Karachi.              		‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
              Terbisil Tablet 250mg
               
              Each tablet contains:
              Terbinafine as hydrochloride……250mg              		473M/s Saffron Pharmaceuticals (Pvt.) Ltd.,
              19 Km, Sheikhupura Road, Faisalabad.              		‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
              Carefen Suspension 450mL
               
              Each 5mL contains:
              Ibuprofen.…..100mg              		CN-37M/s Wellcare Pharmaceuticals.,
              A/7 P.S.I.E., Sargodha.              		Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
              DROPHA Tablet
               
              Each film coated tablet contains:
              Dydrogesterone…..10mg              		DRP-0005M/s Himax Pharmaceutical,
              Plot No. 445, Korangi Industrial Area, Karachi.              		‘Spurious’ as per Section 3(z-b) (i)of the Drugs Act, 1976.
              Paracetamol X-tra 1000ml
               
              Each 1000ml contains:
              Paracetamol……190g
              Brofen……..…..150g
               Caffein…………….50g
              Aspirin……….…70g
              Sorbitol……….150ml              		Mt357M/s Vibra Pharma (Pvt.) Ltd.,
              A-139- Ferozpur Road, Lahore.              		‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.

              Risk StatementFalsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
              Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
              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.

              Recall Alert: Recall of Substandard “Tovir 0.5mg Tablet” Batch No. 55, Manufactured by M/s Adamjee Pharmaceuticals (Pvt.) Ltd, Karachi.

              Ahsan Hafiz Recall Alerts

              Recall Alert

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              DRAP Alert NoNo I/S/06-25-46
              Action Date17th June, 2025.
              Target Audience– National Regulatory Field Force.
              – Pharmacists and Chemists               in Distribution, Pharmacies and Medical Stores
              – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
              – General Public
              Problem / Issue Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

              Therapeutic Goods (s) Affected: –

              Product NamesCompositionBatch DetailsManufactured byTest Results
              Tovir 0.5mg Tablet

               
              Reg. No. 062420              		Each tablet contains:
              Clonazepam………0.5mg              		55M/s. Adamjee Pharmaceuticals (Pvt) Ltd.,
              No. 39, Sector 15, Korangi Industrial Area, Karachi.              		‘Substandard’ on the basis of Content Uniformity test.
              Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
              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 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: PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

                Ahsan Hafiz Recall Alerts

                Recall Alert

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                DRAP Alert NoNo I/S/05-25-45
                Action Date2nd June, 2025.
                Target Audience– National Regulatory Field Force.
                – Pharmacists and Chemists                 in Distribution, Pharmacies and Medical Stores
                – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
                – General Public
                Problem / Issue Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

                Therapeutic Goods (s) Affected: –

                Product NamesCompositionBatch DetailsManufactured byTest Results
                AMLOshine Tablet

                 
                Reg. No. 062420                		Each tablet contains:
                Amlodipine as besylate…..5mg                		7840M/s. Sunshine Pharmaceuticals,
                Khan Payara, Near Saim Nala, Emanabad Gujranwala – Pakistan.                		‘Substandard’ on the basis of Impurities test.
                AMLOshine Tablet

                 
                Reg. No. 062420                		Each tablet contains:
                Amlodipine as besylate…..5mg                		7623M/s. Sunshine Pharmaceuticals,
                Khan Payara, Near Saim Nala, Emanabad Gujranwala – Pakistan.                  		‘Substandard’ on the basis of Impurities test.
                AMLOshine Tablet

                 
                Reg. No. 062419                		Each tablet contains:
                Amlodipine as besylate…..5mg                		7361M/s. Sunshine Pharmaceuticals,
                Khan Payara, Near Saim Nala, Emanabad Gujranwala – Pakistan.                  		‘Substandard’ on the basis of Impurities test.
                FLAZOL Infusion 100mL


                Reg. No. 070611                		Each 100ml vial contains:
                Metronidazole….500mg                		F250028M/s Bosch Pharmaceuticals (Pvt) Ltd.,
                209, Sector 23, Korangi Industrial Area, Karachi.                		‘Substandard’ on the basis of Bacterial Endotoxin Test.
                Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
                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 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.