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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.

            Recall Alert: Drug Product; Barpon 100mg/5mL Suspension (Batch # 202) by M/s. JASM Pharmaceutical, KPK

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            DRAP Alert NoNo II/S/03-24-13
            Action Date13th March 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 etc.
            Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. KQ-11-23-000155 dated 12-12-2023 has declared the subject mentioned product namely Barpon 100mg/5mL (Batch No. 202) as of substandard quality.

            Therapeutic Good(s) Affected: –

            Product NamesCompositionBatch No Manufacturer
            Barpon 100mg/5mL Suspension
             
            Reg No.114785            		IbuprofenBatch No.  202
             
            Mfg Dt: 07-2023
            Exp.Dt: 06-2025            		M/s. JASM Pharmaceutical
            (Pvt.) Ltd., Risalpur.
            Risk Statement:Barpon Infusion contains Ibuprofen, a medicine used to treat mild to moderate pain and fever (high temperature). Administration of substandard products may lead to complications, as well as an increased risk of failure of therapy. The age-profile of patients is important and young patients especially are at risk.
            Action Initiated-The manufacturer has been directed to immediately recall the defective batch of above mentioned product from the market. All pharmacists and chemists working at distributions and pharmacies are hereby advised to 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 DRAP and Provincial Health Departments are also informed regarding the matter and are directed to 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: Contaminated Propylene Glycol Identified and Confiscated

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              Rapid Alert

              DRAP Alert NoNo  II/S/03-24-14
              Action Date8th March 2024
              Target Audience1.Therapeutic Goods industry
              2. Manufactures of Oral liquid preparations
              Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis vide No. RM-2-24-000179 and No. RM-2-24-000180 dated 01-03-2024 declared the sample of Propylene Glycol (Raw material) sent to CDL Karachi by Federal Inspector of Drugs Islamabad-I as of substandard quality due to contamination of DEG and EG. ( Click for details)

              Two samples were collected from separate containers which were labelled as Propylene Glycol, Batch# C815L44R41 and Batch# C815L44R52, purportedly manufactured by Dow Chemical Pacific (Singapore) Private Limited. However, upon further investigation, it seems that none of the samples were actually manufactured by Dow Chemicals and the labels were false.

              It is important to note that on January 11, 2024, a rapid alert was also issued for contaminated Propylene Glycol with batch number C815N3OR41, which was labelled as being manufactured by Dow Chemicals, Thailand. However, Dow Chemicals, Thailand has clarified to DRAP that it was not their original product and was falsified by some miscreants. The company also analyzed the retained samples of the original product and shared an analysis report, which showed that it was in compliance with the required specifications.
              Risk Statement:Diethylene glycol (DEG) and Ethylene Glycol (EG) contamination in Propylene Glycol (PG) can lead to serious health risks when used in oral liquid preparations. Upon ingestion, these chemicals (EG and DEG) are converted into toxic metabolites which can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
              Action Initiated: –The Regulatory Field Force has taken possession of contaminated raw materials and commenced an investigation to trace the supply chain of these containers. Manufacturers of therapeutic goods have been prohibited from using propylene glycol without testing for the presence of EG/DEG levels. These materials should only be obtained from authorized suppliers of original manufacturers with thorough verification of the integrity of the supply chain and originality of the product. The Regulatory Field Force has also been directed to ensure compliance and seize any such raw materials or products found to be contaminated in the market.
              Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
               
              1.      Recall Products: If any batch of finished product has been manufactured using the same batch of the propylene glycol that has been identified as contaminated, the retained sample should be immediately analysed and these finished products should be recalled from local and export markets if found contaminated.


              2       Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.

              3.     Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

              4.    Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

              5.     Follow Guidelines: Adhere to the pharmacopeial monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.

              Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
              Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres.

              -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 stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately 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: Substandard Propylene Glycol (Batch # G01821UG) claimed to be manufactured by SK Picoglobal Korea.

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              Rapid Alert

              DRAP Alert NoNo  I/S/03-24-12
              Action Date8th March 2024
              Target Audience1. Regulatory Field Force.
              2. Therapeutic Goods industry
              3. Manufactures of Oral liquid preparations
              4. Healthcare professionals
              Problem StatementMs. MKB Pharmaceuticals (Pvt) Ltd., Peshawar sent the sample of Propylene Glycol (PG) to Central Drugs Laboratory Karachi for test/analysis that was used as a solvent in the manufacturing of oral liquid preparations. The batch was claimed to be manufactured by SK picoglobal Co. Ltd. Korea. Analysis of the sample by the Central Drug Laboratory, Karachi detected unacceptable level of Ethylene Glycol.

              The product identification details are as under: –

              Therapeutic Good Affected:-

              ProductBatch NoMfg DateExp. DatePurported to be Manufactured by
              (as per label)              		Remarks
              Propylene Glycol
              (Raw Material)              		G01821UG12-08-202311-08-2025SK Picoglobal Co. Ltd. Korea.The sample is declared substandard
              for unacceptable levels of Ethylene Glycol (0.4671%).
              Risk StatementPropylene Glycol (PG) contaminated with Ethylene Glycol (EG) when used in oral liquid preparations, can lead to serious health risks due to EG’s toxicity. When ingested, EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal.
              Action InitiatedThe manufacturer has been instructed to recall finished products that were manufactured using the contaminated lot of propylene glycol. The Regulatory Field Force has also been instructed to seize all oral preparations that were made using the same batch of propylene glycol if found in the market. DRAP has directed the therapeutic goods industry to hold finished products manufactured from any other lot of propylene glycol of Ms. SK picoglobal Co. Ltd. Korea and ensure testing of finished products for EG/DEG contamination before releasing them into the supply chain.
              Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
               
              1.      Recall Products: If any batch was manufactured using the same lot (YF01200730) of propylene glycol that has been identified as contaminated, all finished products from local and export markets should be recalled.

              2.      Hold Other Batches: All finished products manufactured from any other lot of propylene glycol of SK picoglobal Co. Ltd. Korea should be held. These products should be tested for EG/DEG contamination before releasing them into the supply chain.

              3.      Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.

              4.      Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

              5.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

              6.      Follow Guidelines: Adhere to the pharmacopeial monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.

              Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
              Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres.

              -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 stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately 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.