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Month: December 2023

Rapid Alert; Drug Product: Crackdown on Illegal Manufacturing and Seizure of Falsified Drugs

Asad Ullah Recall Alerts
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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; Cetafend Infusion (Batch # 23RC55) by M/s Friends Pharma (Pvt.) Ltd, Lahore

Asad Ullah Uncategorized

Recall Alert

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DRAP Alert NoNo I/S/12-23-47
Action Date28th 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 vide test report No. KQ-11-23-000155 dated 12-12-2023 has declared the Cetafend Infusion Batch No. 23RC55 as of substandard quality.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Cetafend 1g/100mL Infusion
 
Reg.No 091872		ParacetamolBatch No. 23RC55
 
Mfg. Date: 10-2023
Exp. date: 10-2025		M/s. Friends Pharma (Pvt.) Ltd.
Ferozepur Road, Lahore
Risk Statement:Cetafend Infusion contains Paracetamol, a medicine used to treat mild to moderate pain. Paracetamol can also be used to treat fever (high temperature). Administration of products containing visible solid particles to patients through IV infusion may lead to complications, as well as an increased risk of venous thromboembolism. The age-profile of patients is important and young patients especially seem to be at risk.
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; Ketovet 100mg Injection (Veterinary use) (Batch # 2324108) by Vetz Pharmaceutical Pvt. Ltd, kotri

    Asad Ullah Recall Alerts

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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

      Asad Ullah Recall Alerts

      Recall Alert

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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.

        DRAP’s Pharmacovigilance Newsletter (December, 2023 ; Issue-II)

        Asad Ullah General, Pharmacovigilance

        The Pharmacovigilance Newsletter is a quarterly publication that aims to inform and educate the healthcare professionals and the public about the importance of pharmacovigilance and adverse drug reaction reporting. It also showcases the activities of the National Pharmacovigilance Centre (NPC) and initiatives taken by the NPC for monitoring and evaluating the safety of medicines in Pakistan.

        We are pleased to announce that the second issue of the Pharmacovigilance Newsletter (Dec-2023) is now available for download from our website. This issue covers the latest updates on the safety of medicinal products and regulatory actions taken by the Drug Regulatory Authority of Pakistan (DRAP) and other international authorities.

        NPC Newsletter_Dec23Download

        We hope that you will find the newsletter informative and useful. We welcome your feedback and suggestions for improvement. You can contact us at npc∂drap.gov.pk or call us at +92-51-9255980. Thank you for your interest and support in pharmacovigilance.

        Together, we can ensure the safe and effective use of medicines in Pakistan.

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

        Asad Ullah Recall Alerts

        Recall Alert

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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.