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Month: June 2025

Recall Alert: Recall of Substandard “Famobex Suspension” Batch No. 5330, Manufactured by M/s Cibex (Pvt.) Ltd, Karachi.

Ahsan Hafiz Recall Alerts

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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

    Ahsan Hafiz Recall Alerts

    Recall Alert

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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.