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Recall Alert: Drug Product; IS-NS (0.9%) Infusion (Batch # B6-24) by ISIS Pharmaceutical & Chemical Works, Karachi

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DRAP Alert NoNo I/S/12-23-48
Action Date2nd January, 2024
Target Audience·         Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses.
·         Procurement Officers at Hospitals and Healthcare Institutions.
·         Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue Federal Government Analyst, CDL Karachi has declared Batch No. B6-24 of product “IS-NS 0.9% INFUSION” as of Substandard quality.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
IS-NS 0.9% Infusion
 
Reg.No 104066		0.9% Sodium ChlorideBatch No. B6-24
 
Mfg. Date: 08-23
Exp. date: 08-25		M/s. ISIS Pharmaceutical
& Chemical Works, Karachi
Risk Statement:The use of substandard products based on assay tests may alter the dose and hamper the efficacy of the product leading to sub-therapeutic effects.
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) 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 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: Crackdown on Illegal Manufacturing and Seizure of Falsified Drugs

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    Rapid Alert

    DRAP Alert NoNo  I/S/12-23-46
    Action Date29th December, 2023
    Target Audience1. Regulatory Field Force.
    2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
    3. Healthcare Professionals – Physicians, Pharmacists, and Nurses, Procurement officer at hospitals and institutions
    4. General Public.
    Problem StatementOn December 12, 2023, the regulatory field force in Karachi raided and shut down an illegal drug manufacturing facility. They collected product samples and sent them to the Central Drugs Laboratory (CDL) in Karachi for testing. The Federal Government Analyst at the CDL confirmed that the products seized by FID-III Karachi from the illicit site were “spurious”. The test results showed that these products lacked the stated active ingredients. There is a possibility that the fake manufacturers have infiltrated the supply chain with some of their falsified products.
    Threats to Public HealthThe use of falsified products will result in ineffective treatment. This may cause therapy failure which may lead to increased morbidity and also, mortality, in case of untreated infections. Moreover, the safety of these falsified products is also unknown.

    The product identification details are as under: –

    Therapeutic Goods Affected*:-

    Product NameComposition
    (as per label)    		Batch / LotMfg DateExp DateManufacture Name (as stated on label)Illustrative Images
    AL Coxime 400mg
    Capsule    		Cefixime11004-2303-25M/s. Alpine Laboratories (Pvt) Ltd., KarachiSee DRAP Alert
    Sinoxime 100mg/5ml
    Dry Suspension    		Cefixime101S1310-2309-25M/s. Alcons Laboratories Pvt Ltd., Karachi
    Flox-G 500mg TabletLevofloxacin76001-2312-25M/s. Alcons Laboratories Pvt Ltd., Karachi
    Flox-G 250mg TabletLevofloxacin76101-2312-25M/s. Alcons Laboratories Pvt Ltd., Karachi
    Amcox 125mg/5ml
    Suspension    		Amoxicillin2321704-2303-25M/s. Alcons Laboratories Pvt Ltd., Karachi
    Snagxone 1g injectionCeftriaxoneL23-406-2306-25M/s Leckman Laboratories Pvt Ltd., Karachi
    Leckzolid 600mg TabletsLinezolid002—09-24M/s Leckman Laboratories Karachi
    Uniclav 156.25mg/5ml
    Suspension    		Co-amoxiclav12609-2308-25M/s. Uni-Tiech Pharmaceutical Pvt Ltd., Karachi
    *The packaging of these products displays fake Drug Manufacturing Licenses (DML) and Drug Registration Numbers (DRN). None of these products are registered and no manufacturers with these names and addresses are licensed by DRAP.
    Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate/seize these falsified products without any delay. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and halt the distribution/supply of these falsified products. Information related to the supplier of these falsified products should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of these falsified 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 these falsified products.

    -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 not use these falsified products and should contact their physician or healthcare provider if they have experienced any problem related to taking or using any of these falsified products, and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

    All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

    Recall Alert: Drug Product; Ketovet 100mg Injection (Veterinary use) (Batch # 2324108) by Vetz Pharmaceutical Pvt. Ltd, kotri

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    DRAP Alert NoNo I/S/11-23-45
    Action Date21st Dec, 2023
    Target Audience• Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
    • Veterinarians
    • General Public
    Problem / Issue Federal Government Analyst, CDL Karachi has informed DRAP regarding the sample of product namely “Ketovet injection” Batch No. 2324108 manufactured by M/s. Vetz Pharmaceuticals (Pvt.) Ltd., Plot #Q1, S.I.T.E Area, Kotri, Hyderabad has been declared as of “Substandard” quality

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch No Manufacturer
    Ketovet 100mg Injection
    (Veterinary Use)

    Reg.No 102014    		KetoprofenBatch No. 2324108
     
    Mfg. Date: 10-23
    Exp. date: 09-25    		M/s Vetz Pharmaceutical (Pvt) Ltd. Kotri
    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 veterinary 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) 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 Veterinary Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of veterinary pharmacies and facilities likely to be affected by this faulty batch.
    Advice for Consumers-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; Espezar 20mg Tablets (Batch # A401) by Avant Pharmaceutical Pvt. Ltd, Hub, Baluchistan

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      DRAP Alert NoNo I/S/11-23-44
      Action Date21st Dec, 2023
      Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
      ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
      · General Public
      Problem / Issue Federal Government Analyst, CDL Karachi has informed DRAP regarding the sample of product namely “Espezar tablet” Batch No. A401 manufactured by M/s. Avant Pharmaceuticals (Pvt.) Ltd., Plot No. 28 Hub Industrial Estate, Hub Balochistan has been declared as of “Substandard” quality.

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch No Manufacturer
      Espezar 20mg Tablets
       
      Reg.No 102983      		EsomeprazoleBatch No. A401
       
      Mfg. Date: 11-22
      Exp. date: 11-24      		M/s Avant Pharmaceutical
      Pvt. Ltd, Hub, Baluchistan
      Risk Statement:Esomeprazole is used to treat certain stomach and oesophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid the stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). Impact of use of substandard product may leads to sub optimal therapeutic effect which may cause therapy failure or other associated problems.
      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) 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 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.

        Recall Alert: Drug Product; Sterile Water for Injection (Batch # B6-77) by ISIS Pharmaceutical & Chemical Works, Karachi

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        DRAP Alert NoNo I/S/11-23-43
        Action Date8th Dec, 2023
        Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
        ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
        · General Public
        Problem / Issue Federal Government Analyst, CDL Karachi has informed DRAP regarding the sample of product namely “Sterile Water for Injection” Batch No. B6-77 manufactured by M/s. ISIS Pharmaceuticals & Chemical works, 25/1-4, Sector 12-C, North Karachi Industrial Area, Karachi, has been declared as of “Substandard” quality.

        Therapeutic Good(s) Affected: –

        Product NamesCompositionBatch No Manufacturer
        Sterile Water for Injection  
         
         
        Reg.No 048819        		Sterile Water for InjectionBatch No: B6-77
         
        Mfg. Date: August 2023
        Exp. Date: August 2025        		M/s. ISIS Pharmaceutical
        & Chemical Works, Karachi
        Risk Statement:Sterile water for injection is a sterile, non-pyrogenic, and isotonic solution of water that does not contain any additives. It is mainly used as a solvent or diluent for other parenteral drugs, such as antibiotics and administered intravenously, intramuscularly, or subcutaneously.

        Endotoxin is a toxic substance that can cause serious harm such as fever, inflammation, shock, coagulation, and immune suppression. Using endotoxin-contaminated water for injection can lead to life-threatening complications, especially if injected intravenously.
        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) 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 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.

          Recall Alert: Drug Product; Dolor DS 100mg/5mL Suspension (Batch # 1236,1237 and 1238) by Adamjee Pharmaceutical, Karachi

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          DRAP Alert NoNo II/S/10-23-42
          Action Date30th Nov, 2023
          Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
          ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
          · General Public
          Problem / Issue Federal Government Analyst, CDL Karachi has declared the03 Batches of product “Dolor DS Suspension” as of substandard quality.
          The detail of the affected product is as under:

          Therapeutic Good(s) Affected: –

          Product NamesCompositionBatch No Manufacturer
          Dolor DS Suspension  
           
           
          Reg.No 14451
          		Mefenamic AcidBatch No1236, 1237, 1238
           
          Mfg. Date: March 2023
          Exp. Date: March 2025          		M/s. Adamjee Pharmaceuticals
          (Pvt.) Ltd, Karachi
          Risk Statement:Mefenamic acid is used for the short-term relief of mild to moderate pain from various conditions such as headache, dental pain, menstrual cramps, and muscle aches. Inaccurate use of the product may lead to common side effects like skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

          Impact of use of substandard product on basis of pH test may significantly altered the solubility and interfere with its absorption which may leads to sub optimal therapeutic effect.
           
          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) 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 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.

            Recall Alert: Drug Product; Piperazine Elixer (Batch # L-085) by Swat Pharmaceuticals, Swat

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            DRAP Alert NoNo II/S/10-23-41
            Action Date20th Nov, 2023
            Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
            ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
            · General Public
            Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. L085 of product “Piperazine Elixer” as of substandard quality.

            Therapeutic Good(s) Affected: –

            Product NamesCompositionBatch No Manufacturer
            Piperazine 750mg/5ml Elixir
             
            Reg.No  002235

            		Piperazine CitrateBatch No L-085
             
            Mfg. Date: June 2023
            Exp. Date: May 2025            		Ms. Swat Pharmaceuticals,
            Saidu Sharif Swat.
            Risk Statement:Piperazine Citrate is used to treat common roundworms (ascariasis) and pinworms (enterobiasis; oxyuriasis). To avoid the common side effects of gastrointestinal disturbances, headache, dizziness, and urticaria, it is important to use the product accurately.
            It is critical to ensure that the product is not substandard, as its use can significantly alter the dose and lead to suboptimal therapeutic effects.
             
            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) 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 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.

              Recall Alert; Drug Product: Recall of Liquid Preparations for Suspected Contamination of DEG/EG Impurities by M/s Pharmix Laboratories, Lahore

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              DRAP Alert NoNo I/S/11-23-40
              Action Date16th November 2023
              Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
              ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
              · General Public
              Problem / Issue DRAP has issued a recall of certain batches of liquid preparations due to suspected contamination with diethylene glycol (DEG) and ethylene glycol (EG).
              WHO has also informed the suspected presence of DEG/EG impurities in batch No. B220 of Alergo Syrup, (identified in the Maldives) which was manufactured by M/s. Pharmix Laboratories (Pvt.) Ltd., Lahore.
              Following a preliminary investigation conducted by DRAP Lahore, it is suspected that these impurities may also be present in other batches and products mentioned below. This recall is a precautionary measure taken to safeguard public health against the potential harmful effects of these impurities

              Therapeutic Good(s) Affected: –

              Product NamesBatch No Manufacturer
              Mucorid Syrup

              		A230, C227, A211, A212,
              B201, L111, A210, A230,
              B224, L121, C210, B201,
              B225              		M/s. Pharmix Laboratories (Pvt.) Ltd.,
              21-Km Ferozpur Road, Lahore.
              Ulcofin SuspensionB209, C223-do-
              Alergo syrupB220, L126do-
              Emidone SuspensionB227do-
              Zincell SyrupC218do-
              Risk Statement:Between 2022 and 2023, several countries reported incidents of oral liquid drugs that were intended for children and were found to be contaminated with high levels of DEG and EG. These incidents lead to severe adverse events and fatalities in few countries.
              Action Initiated-The manufacturing company has been directed to immediately recall the defective batches of the above-mentioned products from the market. All pharmacists and chemists working at distributions and pharmacies are hereby advised to immediately check their stocks and stop supplying these batches of suspected products. 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 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.

                Recall Alert: Drug Product; Weena Syrup (Batch # L-090) by Swat Pharmaceuticals, Swat

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                DRAP Alert NoNo II/S/10-23-39
                Action Date6th Nov, 2023
                Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
                ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
                · General Public
                Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. L090 of product “Weena Syrup” as of substandard quality.

                Therapeutic Good(s) Affected: –

                Product NamesCompositionBatch No Manufacturer
                Weena Syrup
                 
                Reg.No  003049

                		Ferrous sulfate and ascorbic acidBatch No L-090
                 
                Mfg. Date: May 2023
                Exp. Date: Apr 2025                		Ms. Swat Pharmaceuticals,
                Saidu Sharif Swat.
                Risk Statement:Ferrous sulphate and ascorbic acid are used to treat and prevent iron deficiency anemia, as well as in prophylaxis for iron deficiency. Incorrect usage of the product can lead to common side effects, including various types of gastrointestinal distress such as nausea, diarrhea, vomiting, abdominal pain, constipation, and dark or discolored stool.
                The use of substandard products may significantly alter the dose, which can lead to suboptimal therapeutic effects.
                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) 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 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.

                  Recall Alert: Drug Product; Zolan 200mg/5ml Suspension (Batch # L-083) by Swat Pharmaceuticals, Swat

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                  DRAP Alert NoNo II/S/10-23-35
                  Action Date4th Oct, 2023
                  Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
                  ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
                  · General Public
                  Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. L083 of product “Zolan suspension” as of substandard quality.

                  Therapeutic Good(s) Affected: –

                  Product NamesCompositionBatch No Manufacturer
                  Zolan 200mg/5mL Suspension
                   
                  Reg.No  027683

                  		Metronidazole benzoateBatch No L-083
                   
                  Mfg. Date: May 2023
                  Exp. Date: Apr 2025                  		Ms. Swat Pharmaceuticals,
                  Saidu Sharif Swat.
                  Risk Statement:Metronidazole benzoate oral suspension is commonly used to treat bacterial infections and intestinal parasites. Inaccurate use of the product may lead to common side effects like nausea, vomiting, diarrhea, and abdominal discomfort; more severe reactions, such as convulsive seizures and peripheral neuropathy, may also occur.
                   
                  The impact of the use of substandard products on the basis of noncomplying pH may significantly alter the stability, and solubility of the product and may interfere with its absorption which could lead to sub-optimal therapeutic effect.
                  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) 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 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.