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Author: Muhammad Ayub Naveed

Rapid Alert: CRACKDOWN AGAINST FALSIFIED/SPURIOUS DRUGS

Muhammad Ayub Naveed Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/02-25-20
Action Date20th February, 2025
Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
3. General Public
Problem StatementDrug Testing Laboratory, Sindh has notified the Drug Regulatory Authority of Pakistan that samples of following products, collected by various provincial drug inspectors, have been declared ‘Spurious’ (falsified). The details of the reports are as below:

The product identification details are as under:

Therapeutic goods affected:

ProductBatch No*Mfg DateExp. DateManufacturer Name
(as per label)		Remarks
Nuberol Forte Tablets (Paracetamol & Orphenadrine citrate)DB0982Purported to be manufactured by M/s Searle Company Limited, 32-Km Multan Road, LahoreSpurious, Orphenadrine Citrate not identified.
Phenobar Tablet
(Phenobaritone)		QA 008Purported to be manufactured byM/s Star Laboratories (Pvt) Ltd, 23-Km Multan Road, LahoreSpurious, Phenobarbitone not identified.
Iodex CMS Ointment (Methyl Salicylate)HIAACPurported to be manufactured by M/s GSK Pakistan Limited, F/168, SITE, Karachi.Spurious, Methyl Salicylate not identified.

Risk Statement:Falsified 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 throughout the supply chain to confiscate the counterfeit 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 supplier of such product should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of this product from the circulation.
Advice for Healthcare ProfessionalsAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products.

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 at this link.
Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.

Recall Alert: Voluntary Recall of 36 Batches of Motival Tablets (Reg # 004539) Manufactured by M/s GSK Pakistan Limited, Karachi.

Muhammad Ayub Naveed Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/02-25-18
Action Date18th February 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 firm M/s GSK Pakistan Limited, Karachi has notified Drug Regulatory Authority of Pakistan that they have initiated voluntary recall of 36 batches of Motival Tablets due to the detection of nitrosamine impurity, N-nitroso nortriptyline. Moreover, the firm has reported that it has ceased the manufacture and release of Motival Tablets. The details of the recalled product lots are as follows:

Therapeutic Goods (s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Motival Tablets
5 × 20’s
 
(Reg # 004539)
 

Nortiptyline as HCl 10mg + Fluphenazine HCl 0.5mg
Batch No.
9P8L, A95S, A95Y, AN5N, AN5P, AN5R, AN5T, CK7G, CK7H, DT7B, DT7D, DL8J, DT7C, H58X, H58Y, H59A, J77W, J77V, K36F, K36E, KD6N, KD6P, M32F, ME8N, ME8R, R47H, R47K, R47L, SA7F, SA7G, SA6V, WM8R, WM8T, WM8U, YB7A, YB7B.		M/s. GSK Pakistan Limited, Plot # 5, Sector 21, Korangi Industrial Area, Karachi.
Risk Statement:The risk of nitrosamine impurity in nortriptyline, like other pharmaceutical products, is a broader concern that has become more prominent after several incidents. These impurities are believed to have carcinogenic potential in certain situations.
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

    Muhammad Ayub Naveed Uncategorized
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    Rapid Alert

    DRAP Alert NoNo  I/S/02-25-18
    Action Date17th February, 2025
    Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
    2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
    3. General Public
    Problem StatementDrug Testing Laboratory, Sindh has informed to Drug Regulatory Authority of Pakistan that samples of following products taken by various provincial drug inspectors, have been declared ‘Spurious’ (falsified). Moreover, the following firms and their associated products were found to be fictitious. The details of the reports are as below:

    The product identification details are as under:

    Therapeutic goods affected:

    ProductBatch No*Mfg DateExp. DateManufacturer Name
    (as per label)    		Remarks
    Evosef 250mg capsule
    (Cephradine 250mg)    		HF-001Purported to be manufactured by East Pharmaceutical 19-Km Sheikhupura road, LahoreSpurious. Cephradine not identified
    Mirzpan Suspension 100mg/5ml
    (Cefixime)    		0008M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur.Spurious, Cefixime not identified
    Mirzolam Tablet 0.5mg (Alprazolam)0007M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur.Spurious, Alprazolam not identified
    Bromalax Tablet 3mg (Bromazepam)B-01M/s Brom Pharmaceuticals (Pharmaceutical Industries), 21-Km Ferozpur Road, Lahore.Spurious, Bromazepam not identified
    Malixime Suspension 200mg/5ml
    (Cefixime)    		78011M/s Menakline Pharma, S Site Plot 11, Korangi Industrial Area, Karachi.Spurious, Cefixime not identified
    Lexopam Tablet 3mg (Bromazepam)B-01M/s Porm Pharmaceuticals (Pharmaceutical Industries), 220 Industrial Estate Hayatabad, Peshawar.Spurious, Bromazepam not identified
    Zionex Tablet 0.5mg (Alprazolam)0032M/s Multicare Pharmaceutical, Plot # 23, Korangi Industrial Area, Karachi.Spurious, Alprazolam not identified
    Tramaking-225 Mega tablet 225mg
    (Tramadol HCl)    		TRD2002Name of Manufacturer not mentioned.Spurious
    Alcoxime Suspension 100mg/5ml
    (Cefixime)    		A2011M/s Alpine Laboratories (Pvt.) Ltd: Plot# A-41, S.I.T.E Indsutrial Area, Sector 3 North Karachi Super Highway 75500-Pakistan.Spurious, Cefixime not identified

    Risk Statement:Falsified 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 throughout the supply chain to confiscate the counterfeit 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 supplier of such product should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of this product from the circulation.
    Advice for Healthcare ProfessionalsAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products.

    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 at this link.
    Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.

    Recall Alert: Substandard Products Declared By Provincial Drug Testing Laboratories.

    Muhammad Ayub Naveed Recall Alerts

    Recall Alert

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    DRAP Alert NoNo I/S/01-25-16
    Action Date7th January 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 DRAP that samples of below product have been reported as substandard due to the presence of impurities by the Drug Testing Laboratory (DTL) Lahore.

    Therapeutic Goods (s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by
    AMLOShine 10mg

     

    		(Amlodipine 10mg)
    Batch No.
    7180    		Sunshine Pharmaceuticals, Khan Payara, Near Saim Nala, Eimanabad road, Gujranwala
    Bytec tablet
    		(Cetrizine 2HCl 10mg)Batch No.
    E088    		Batala Pharmaceuticals, 23/B Small Industrial Estate #2, Gujranwala
    Risk Statement:Use of substandard products can lead to therapy failure, which can increase chances of complications in susceptible users including immunocompromised patients, pediatric and geriatric populations.
    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 Products

      Muhammad Ayub Naveed Recall Alerts
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      Rapid Alert

      DRAP Alert NoNo  I/S/02-25-15
      Action Date7th January, 2025
      Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
      2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
      3. General Public
      Problem StatementProvincial Government Analyst, Drug Testing Laboratory Karachi has informed DRAP that samples below product has been identified as spurious (falsified):

      The product identification details are as under:

      Therapeutic goods affected:

      ProductBatch No*Mfg DateExp. DateManufacturer Name
      (as per label)      		Remarks
      Evosef 250mg capsule
      (Cephradine 250mg)      		HF-001Purported to be manufactured by East Pharmaceutical 19-Km Sheikhupura road, LahoreSpurious. Cephradine not identified
      Tramaking-225 Mega tablet
      (Tramadol HCl 225mg)      		TRD2002Name of Manufacturer not mentionedSpurious

      Risk Statement:Falsified 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 throughout the supply chain to confiscate the counterfeit 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 supplier of such product should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of this product from the circulation.
      Advice for Healthcare ProfessionalsAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products.

      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 at this link.
      Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.

      Rapid Alert: Presence of Counterfeit and Trademark Infringement Case of Laroscorbine Platinum Injection in the Market

      Muhammad Ayub Naveed Recall Alerts
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      Rapid Alert

      DRAP Alert NoNo  I/S/02-25-14
      Action Date4th February, 2025
      Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
      2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
      3. General Public
      Problem StatementM/s Roche Pakistan Limited, Karachi, has notified DRAP, regarding the sale of counterfeit ‘Laroscorbine Platinum Injection’ in the market across Pakistan. According to the principal, Roche manufactured and marketed Laroscorbine until 2005. In that year, Roche sold the product and brand to Bayer AG. Therefore, any Laroscorbine offered for sale, and which is labeled with the Roche logo or which claims that it was manufactured or marketed by Roche, is not a genuine Roche product. Further informed that as the product does not belong to Roch portfolio, tracing of the lot is not possible:

      The product identification details are as under:

      Therapeutic goods affected:

      ProductBatch No*Mfg DateExp. DateManufacturer Name
      (as per label)      		Remarks
      Laroscorbine Platinum Injection
       
      Reg. No. 0326422      		Purported to be manufactured by M/s Roche Pakistan Limited, Karachi.Spurious

      Risk Statement:The use of Laroscorbine Platinum Injection is believed to brighten the skin and maintain skin elasticity. However, the administration of counterfeit productscould result in treatment failure, worsening of the disease, or life threatening consequences
      Action InitiatedThe Regulatory field force has been directed to conduct surveillance activities throughout the supply chain to confiscate the counterfeit 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 supplier of such product should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of this product from the circulation.
      Advice for Healthcare ProfessionalsAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products.

      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 at this link.
      Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.

      Recall Alert: Substandard Flagyl Injection Batch No. Ad482 Manufactured by M/S. Sanofi Aventis Pakistan Limited, Karachi. 

      Muhammad Ayub Naveed Recall Alerts

      Recall Alert

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      DRAP Alert NoNo I/S/01-25-13
      Action Date28th January 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 Senior Drug Inspector ICT Islamabad has informed DRAP that samples below product has been reported substandard by Drug Testing Laboratory (DTL) Rawalpindi:

      Therapeutic Goods (s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by
      Flagyl Injection 100ml
       

      		Metronidazole 500mg
      Batch No.
      AD482      		M/s. Sanofi Aventis Pakistan Limited,
      Plot No. 23, Sector 22, Korangi industrial area, Karachi
      Risk Statement:Endotoxin containing intravenous products can lead to a range of consequences, including fever, chills, shock, organ failure, which can even prove fatal. Even small amounts of endotoxin in an injection can cause significant harm, particularly in vulnerable individuals like immunocompromised patients or those with pre-existing medical conditions.
      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: Presence of Falsified Mirzpan Suspension 100mg/5ml Purportedly Manufactured by M/s. Miraz Pharma, Kasur.

        Muhammad Ayub Naveed Recall Alerts
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        Rapid Alert

        DRAP Alert NoNo  I/S/01-25-12
        Action Date23rd January, 2025
        Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
        2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
        3. General Public
        Problem StatementSecretary, PQCB Balochistan, has informed DRAP that sample of following product, manufactured by M/s Miraz Pharma, Kasur, has been declared “Spurious”, “Unregistered” and “Misbranded” by the Drug Testing Laboratory, Quetta. The sample portion “Suspension Mirzpan” contains no Active Pharmaceutical Ingredient (Cefixime), bears a fake registration number in seven digits, and exhibit a pH value of 6.51, which is outside the USP specified range of 2.5 – 4.5. Additionally, the outer packaging contains multiple spelling errors, as well as ambiguous and misleading information. The details of sample are as under::

        The product identification details are as under:

        Therapeutic goods affected:

        ProductBatch No*Mfg DateExp. DateManufacturer Name
        (as per label)        		Remarks
        Mirzpan Suspension 100mg / 5ml
         
        Reg. No. 0326422        		00711-202311-2025Purported to be manufactured by M/s Miraz Pharma, Plot No. 23, Qasoor Industries, Kasur.Spurious

        Risk Statement:The presence of falsified cefixime suspension poses significant risks to patient health, including potential therapeutic failure, inadequate treatment of bacterial infections, and the development of antibiotic resistance.
        Action InitiatedThe field force under administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market.
        Advice for Healthcare ProfessionalsAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products.

        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 at this link.
        Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.