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Rapid Alert: Busting of Illegal Manufacturing Site producing Unregistered Boostin (RBST) Injections

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Rapid Alert

DRAP Alert NoNo I/S/05-24-25
Action Date10th June 2024
Target Audience·         National Regulatory Field Force.
·         Distribution, Pharmacies and Medical Stores
·         Healthcare Professionals – Veterinarians, Chemists
·         Farmers/Consumers 
Problem StatementDuring a joint raid by DRAP and FIA, illegal manufacturing of Boostin Injections (Synthetic Recombinant Bovine Somatotropin Hormone) was unearthed at Chandio Village, Clifton, Karachi. A large quantity of raw materials used in the manufacturing of Boostin Plus 2g Injections, finished goods, empty cartridges/containers with needles, packing materials/stickers, and packing machinery were seized from the premises as per Form-2 under Section 18(1) of the Drug Act 1976.
Threat to Public HealthRBST (a synthetic recombinant Bovine Somatotropin hormone) injected into animals for enhancing their milk production was banned in the country due to serious side effects on health of animals and impact on those consuming milk and meat of such animals. The product is also banned in Europe, Canada, Australia etc.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities in markets to confiscate the product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force in order to ensure the removal of this products. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of this product.
Advice for VeterinarianDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link
Advice for Farmers/ConsumerFarmers/Consumers should not use this product. They shall contact their physician or healthcare provider(s) if the animal experienced any problem that may be related to using this product.

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: Drug Product; Water for Injection (Batch 989) by Zafa Pharmaceutical Pvt Ltd, Karachi

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DRAP Alert NoNo I/S/06-24-26
Action Date09th June 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 Drug Inspector in Karachi collected a sample of Sterile Water for Injection and sent for laboratory analysis. Federal Government Analyst at CDL Karachi has declared Batch No. 989 of the product as substandard.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Sterile Water for Injection

Reg No. 030217
Water for InjectionBatch No. 989
 
Mfg Date:03-2023
Exp Date:03-2028		M/s. Zafa Pharmaceutical
Laboratories Private Limited Karachi.
Risk Statement:Using non-sterile water for reconstitution of injectable medications can lead to bacterial and fungal infections, and may cause poor dissolution of the powder. It could also result in precipitation or deactivation of the active pharmaceutical ingredient, posing significant health risks.
Action Initiated–The manufacturer has been directed to immediately recall the defected batch of product from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) also increased surveillance in the market to ensure the effective recall of defective products(s).

–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 through phone at +92 51 910 73 17, 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.

    Voluntary Recall Alert: Drug Product; Cadlec 30mg/mL Injection by Brooks Pharma Pvt Ltd., Karachi

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    DRAP Alert NoNo I/S/05-23
    Action Date15th May 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 M/s. Brookes Pharma Private Limited, Karachi, has initiated a voluntary recall of all batches of Cadlec 30mg/ml Injection due to the presence of tiny floating particles found in retained samples. Previously, Ketorolac injection was also recalled by Fresenius Kabi, USA, and Hospira Inc. Additionally, Hikma Pharmaceutical, USA, also recalled the injection for the same reason.

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by
    Cadlec Injection 30mg/ml

    Reg No. 095892
    		KetorolacAll Batches
    		M/s. Brookes Pharma
    Private Limited, Karachi
    Risk Statement:Administering products containing particulate matter may block blood vessels, leading to local irritation, swelling, tissue inflammation, blood clots, lung tissue scarring, and life-threatening allergic reactions.
    Action Initiated–The manufacturer has initiated recall of all batches of the affected product from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying this product. The remaining stock should be quarantined and returned to the supplier/ company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s).

    –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 through phone at +92 51 910 73 17, 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 and 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: Drug Product; Falsified Froxime 100mg/5mL Powder for Oral Suspension

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      Rapid Alert

      DRAP Alert NoNo I/S/05-24-22
      Action Date27th May 2024
      Target Audience·         Regulatory Field Force.
      ·         Healthcare Professionals – Physicians, Pharmacists, and Nurses.
      ·         Procurement Managers at Hospitals, Clinics, Pharmacies and other Healthcare Institutions
      ·         General Public.
      Problem StatementThe Provincial Inspector of Drug Tehsil Kallurkot, Dist. Bhakkar inspected the premises of Ms. Dar ul Shifa Pharmacy near THQ Hospital Tehsil Kallur Kot district Bhakkar and collected samples of Froxime Suspension (Batch no FRX-100/S-005; manufactured by Ms. Froxx Pharmaceuticals Plot No 87 KIA Karachi). The Government analyst DTL Rawalpindi has declared the Froxime Suspension as Substandard and Spurious.

      The product identification details are as under: –

      ProductCompositionBatch DetailsPurported to be Manufactured by
      (as per label)
      Froxime 100mg/5mL

      Powder for oral Suspension
       
      Reg No. 555210
      (It is fake number)
      		Cefixime USPBatch No.FRX-100/S-005

      Mfg. Date: 03-23
      Exp. Date:  02-25      		Ms. Froxx Pharmaceuticals
      Plot No 87 Korangi Industrial Area, Karachi.
      (It is a Fake company)

      Note: There is no product registered in DRAP with the name “Froxime Powder for Oral Suspension”, and there is no licensed manufacturing company named as “Froxx Pharmaceutical Karachi”.

      Threat to Public HealthSpurious or falsified pharmaceuticals may contain harmful levels of toxic substances, posing a significant risk of widespread poisoning. These substandard medications have the potential to undermine the efficacy of disease treatment and exacerbate preexisting medical conditions.
      Action InitiatedThe Regulatory Field Force has been instructed to increase surveillance activities at health facilities (hospitals), as well as markets, and confiscate any such falsified products. All pharmacists and chemists working at distributions and pharmacies should immediately check their stock and stop supplying any suspected products.. The remaining stock should be quarantined immediately, and supplier information should be provided to the Regulatory Field Force (DRAP, Provincial and State Drug Control Administrations) to ensure the removal of these products.
      Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product.

      -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 stop using this product and shall contact 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 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: Drug Product; Zaftolin 5mg/ml Solution by Zafa Pharmaceutical Pvt Ltd, Karachi

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      DRAP Alert NoNo I/S/05-24-21
      Action Date15th May 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 Provincial Drug Inspector, Karachi took the sample of Zaftolin Respiratory Solution for respirator. Federal Government Analyst, CDL Karachi has declared the Batch No. 104 of the product as of substandard quality. Details of the product are given as under:

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by
      Zaftolin 5mg/ml
      Respiratory solution

      Reg No. 039618
      		SalbutamolBatch No. 104

      Mfg. Date: 06-23
      Exp. date: 06-26      		M/s. Zafa Pharmaceutical
      Laboratories Private Limited Karachi.
      Risk Statement:The impact of use of substandard Zaftolin solution for respirator on the basis of pH may cause sub optimal effect.
      Action Initiated–The manufacturer has been directed to immediately recall the defected batch of product from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s).

      –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 through phone at +92 51 910 73 17, 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: Drug Product; Novarise 50mg/5ml Syrup by Sharooq Pharmaceuticals, Lahore

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        DRAP Alert NoNo I/S/05-24-20
        Action Date15th May 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 Federal Government Analyst, CDL Karachi vide test report No. LHR-1-24-000001 dated 03-04-2024 has declared the Novarise Syrup Batch No. 113 as of substandard quality on the basis of presence of Ethylene Glycol impurity at unacceptable level.

        Therapeutic Good(s) Affected: –

        Product NamesCompositionBatch No Manufactured by
        Novarise 50mg/5mL
        Syrup
        		Iron (iii) Hydroxide
        Polymaltose complex        		Batch No. 113M/s Sharooq
        Pharmaceuticals (Pvt.)
        Ltd., Lahore
        Risk Statement:The presence of Ethylene Glycol (EG) in oral liquid preparations poses serious health risks due to its toxicity as small amounts of EG can be fatal, especially for children. When ingested, both diethylene glycol (DEG) and EG are metabolized into toxic compounds that can adversely affect the central nervous system, heart, and kidneys.
        Action Initiated–The manufacturer has been directed to immediately recall the defective batches of affected products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of products.

        –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 through phone at +92 51 910 73 17, 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; Drug Products: Mebzole 100mg/5mL Suspension and Bioris 1mg/ml Oral Solution by M/s Biolabs Pvt., Ltd., Islamabad

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          DRAP Alert NoNo I/S/04-24-18
          Action Date29th April 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 Federal Government Analyst, CDL Karachi has declared the following batches of oral liquid preparations manufactured by M/s Biolab Pvt Ltd, Islamabad as of “Sub-standard” quality based on the presence of Ethylene Glycol impurity at an unacceptable level.

          Therapeutic Good(s) Affected: –

          Product NamesCompositionBatch No Manufactured by
          Mebzole 100mg/5mL Suspension
           
          Reg No. 046308          		MebendazoleBatch No. 22J022(F), 22J022(B)

          Mfg. Date: 09-22
          Exp. date: 08-24          		M/s. Biolabs
          (Private.) Limited.,
          Islamabad.
          Bioris 1mg/ml Oral Solution
           
          Reg No. 069917          		RisperidoneBatch No. 23B061


          Mfg. Date: 02-23
          Exp. date: 01-25          		M/s. Biolabs
          (Private.) Limited.,
          Islamabad.
          Risk Statement:The presence of Ethylene Glycol (EG) in oral liquid preparations poses serious health risks due to its toxicity as small amounts of EG can be fatal, especially for children. When ingested, both diethylene glycol (DEG) and EG are metabolized into toxic compounds that can adversely affect the central nervous system, heart, and kidneys.
          Action Initiated–The manufacturer has been directed to immediately recall the defective batches of affected products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of products.

          –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 through phone at +92 51 910 73 17, 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; 03 Batches of Veterinary Drug Products by M/s Biolabs Pvt., Ltd., Islamabad

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            DRAP Alert NoNo I/S/04-24-16
            Action Date28th April 2024
            Target Audience– National Regulatory Field Force. 
            – Points of sale and distributors of veterinary medicine. 
            – Veterinary Doctors and professionals. 
            – General Public 
            Problem / Issue The Federal Government Analyst, CDL Karachi has declared has declared the following 03 batches of veterinary drug products, manufactured by M/s. Biolabs (Private) Limited, Islamabad as “Adulterated” based on the presence of unaccepted level of Ethylene Glycol and Diethylene Glycol impurities.

            Therapeutic Good(s) Affected: –

            Product NamesCompositionBatch No Remarks 
            Clo-Animectin Injection 
             
            Reg No.095618            		Clorsulon 100mg/ml 
            Ivermectin 10mg/ml             		Batch No. 009A24 
             
            Mfg. Date: 01-24 
            Exp. date: 12-25             		Sample is “Adulterated” due to presence of: 
            Ethylene Glycol: 14.36% 
            Diethylene Glycol: 2.92% 
            Bio-Oxicam 0.75% Injection 

            Reg No.088836            		Meloxicam 7.5mg/ml Batch No. 083C23 
             
            Mfg. Date: 03-23 
            Exp. date: 02-25             		Sample is “Adulterated” due to presence of
            Ethylene Glycol: 24.19% 
            Bio-E-Floxacin 10% Injection 

            Reg No.088834            		Enrofloxacin 100mg/ml Batch No. 047K22 
             
            Mfg. Date: 10-22 
            Exp. date: 09-24             		Sample is “Adulterated” due to presence of 
            Ethylene Glycol: 12.08% 
            Risk Statement:EG (Ethylene Glycol) is a toxic substance that can have serious adverse effects. EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal. Although, there is no available data on the systemic absorption of injected EG, and no instances of human or animal toxicity from injection of EG have been reported in the literature.
            Action Initiated–The manufacturer has been directed to immediately recall the defected batch of product from the market. All personnel working at distributions and point of sales of veterinary medicine should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s). 

            –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 through phone at +92 51 910 73 17, 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 Veterinary 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.  

              Recall Alert; Drug Products: Artecid 75mg/3mL Injections by M/s Biolabs Pvt., Ltd., Islamabad

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              DRAP Alert NoNo I/S/04-24-17
              Action Date28th April 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 Federal Government Analyst, CDL Karachi has declared the batch number “23E018” of Artecid 75mg/3mL Injection, manufactured by M/s. Biolabs (Private) Limited, Islamabad as “Adulterated” based on the presence of unaccepted level of Ethylene Glycol impurity.

              Therapeutic Good(s) Affected: –

              Product NamesCompositionBatch No Manufactured by
              Artecid 75mg/3mL Injections
               
              Reg No.075186              		Diclofenac SodiumBatch No.  23E018
               
              Mfg Dt: 05-2023
              Exp.Dt: 04-2025              		M/s. Biolabs
              (Private.) Limited.,
              Islamabad.
              Risk Statement:EG (Ethylene Glycol) is a toxic substance that can have serious adverse effects. EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal. Although, there is no available data on the systemic absorption of injected EG, and no instances of human or animal toxicity from injection of EG have been reported in the literature.
              Action Initiated–The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s). 

              –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 through phone at +92 51 910 73 17, 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 this 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: Drug Product; Falsified Risek 40mg Injection identified in the Market

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                Rapid Alert

                DRAP Alert NoNo I/S/03-24-15
                Action Date26th March 2024
                Target Audience·         Regulatory Field Force.
                ·         Healthcare Professionals – Physicians, Pharmacists, and Nurses.
                ·         Procurement Managers at Hospitals, Clinics, Pharmacies and other Healthcare Institutions
                ·         General Public.
                Problem StatementThe Federal Inspector of Drugs Karachi identified suspected samples of Risek 40mg Injection co-packed with Sterile Water for Injection from the market and sent them to the Central Drug Laboratory (CDL), Karachi for testing/analysis. The Federal Government Analyst, CDL has declared the sample as falsified/spurious under section 3(z-b) (ii) of the Drugs Act 1976.  The samples were also declared as substandard for not complying with the assay test.

                The product identification details are as under: –

                Therapeutic Good Affected:-

                ProductCompositionBatch DetailsPurported to be Manufactured by
                (as per label)
                Risek 40mg injection
                 
                Reg No. 024170
                		OmeprazoleBatch No.059PA5

                Mfg. Date: 11-22
                Exp. Date:  05-25                		Getz Pharma Pvt Limited Karachi.
                (as per label)

                During the investigation when the suspected samples were compared with the original product of Getz Pharma, Karachi, significant variations were revealed in various segments of the samples. Please click for details.

                Threat to Public HealthSpurious or falsified pharmaceuticals may contain harmful levels of toxic substances, posing a significant risk of widespread poisoning. These substandard medications have the potential to undermine the efficacy of disease treatment and exacerbate preexisting medical conditions.
                Action InitiatedThe Regulatory Field Force has been instructed to increase surveillance activities at health facilities (hospitals), as well as markets, and confiscate any falsified products. All pharmacists and chemists working at distributions and pharmacies should immediately check their stock and stop supplying any suspected products that differ from the original. Such stock should be quarantined immediately, and supplier information should be provided to the Regulatory Field Force (DRAP, provincial and state drug control administrations) to ensure the removal of these products.
                Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product.

                -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 stop using this product and shall contact 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 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.