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Recall Alert: Drug Products; Recall of 12 Substandard Batches from the Market

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DRAP Alert NoNo I/S/05-24-28
Action Date14th 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 The Directorate of Drugs Control (DDC) Punjab vide Alert No. 137/2024 and 135/2024 has informed that the following samples of drug products have been declared as Substandard by Drug Testing Laboratories (DTL). The Details of affected product batches is tabulated below.

Therapeutic Good(s) Affected: –

S#Product NameCompositionBatch No.Manufactured byTest Results  
01Metroin 100ml infusionMetronidazoleMT23-014M/s. Saturn Pharmaceuticals, Lahore.Substandard
02Tozen-D Ophthalmic SuspensionTobramycin and DexamethasoneTW019M/s. Epharm Laboratories, Karachi.Substandard
03Ann-Vil 50ml InjectionPheniramine MaleateV-44423M/s. Venus Pharma, Lahore.Substandard
04Arpes 500mg Powder for InjectionAcyclovirAR-099M/s. MTI Medical, Lahore.Substandard
05Torax 60ml SyrupAcefylline Piperazine and Diphenhydramine24-24M/s. Siza International, Lahore.Unacceptable Ethylene Glycol level identified
06Zonid 200mg/5ml syrup 120ml Metronidazole BenzoateZ396
Z244
Z243
Z413
Z398
Z414
Z397		M/s. Bloom Pharmaceuticals, Hattar.Unacceptable Ethylene Glycol level identified
Action Initiated–The manufacturers have been directed to immediately recall the defected batches of their products from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of abovementioned product. The remaining stock 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 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.

    Rapid Alert: Crackdown Against Spurious/falsified Drug Products

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    Rapid Alert

    DRAP Alert NoNo I/S/06-24-27
    Action Date14th June 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 Directorate of Drugs Control (DDC) Punjab vide Alert No. 137/2024 has informed that the following samples of drug products have been declared as “Spurious” by Drug Testing Laboratories (DTL) Multan, Lahore, Rawalpindi, and Faisalabad. Details of affected products are as follows:.

    The details of affected products and their batches are as under: –

    S#Product NameBatch No.Purported to be Manufactured by
    (as per label)    		Batch No.
    01Powder Amox 500 (1kg)

    (veterinary use)    		0010823Imported by: M/s. Brand Station, Lahore.
    Mfg. by: M/s. The North Star Import Export
    Joint Stock Company, Can Tho City, Vietnam.    		Spurious
    02Nutricare Syrup 450mlNC-457M/s. Care Pharmaceuticals.Spurious
    03Velosef 500mg Capsule847MM/s. GSK, Karachi.Spurious
    04Pyodine Solution 60ml04813M/s. Brookes Pharma, Karachi.Spurious
    05Pyodine Solution 450ml08913M/s. Brookes Pharma, Karachi.Spurious
    06Tanzo 0.5g InjectionPN220142M/s. Bosch Pharmaceuticals, Karachi.Spurious
    07Dydowen 10mg Tablet736M/s. Weather Fold Pharmaceuticals, Hattar.Spurious
    08Duphaston 10mg Tablet230672
    230092    		Mfg. by: Highnoon Laboratories Lahore.
    Mfg for: Abbott Laboratories, Karachi.    		Spurious
    09Cefspan 400mg CapsuleD6780M/s. Barrett Hodgson Pakistan, Karachi.Spurious
    10Phenobar 30mg TabletQA023M/s. Star Laboratories, Lahore.Spurious
    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. The safety and quality of the falsified products referenced in this alert is unknown.
    Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. 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 to halt the distribution/supply of this product. Information related to the supplier of this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of this product.
    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.

    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.