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Month: November 2024

Recall Alert: Recall Notices for 7 products Issued By Provincial Drug Testing Laboratories

Muhammad Ayub Naveed Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/11-24-50
Action Date29th November, 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 TDDCP PV Lahore and Secretary PQCB Quetta has informed DRAP regarding recall of following batches of mentioned products:

Therapeutic Good(s) Affected: –

Sr.No.Product NamesCompositionManufactured byTest Results
1.Infusion Zeesol-5 1000 mL

Reg# 016611		Dextrose Anhydrous 50 g/ 1000mLShazeb Pharmaceutical Industries Limited Hazara Trunk Road, Sarai Gadaee, District Haripur, K.P.K PakistanSubstandard on the basis of Bacterial Endotoxin
2.Sterile Water for Injection 5 mL

Reg# 062671		Sterile Water for InjectionFynk Pharmaceuticals 19-KM. G.T. Road, Kalashah Kaku, LahoreSubstandard” on the basis of Visible Particulates in Injections
3.Infusion Cyanoco (Vitamin B12) 100mL

Reg# 041241		Cyanocobalamin 500 mcg/2mLInternational Pharma Labs Raiwind Road Bhobatian Chowk, Defence Road, 1-KM, towards Kahna LahoreAdulterated
4.Infusion Cyanoco Super 100mL

Reg# 041242		Cyanocobalamin 1000 mcg/2mLInternational Pharma Labs Raiwind Road Bhobatian Chowk, Defence Road, 1-KM, towards Kahna LahoreAdulterated
5.Syrup Desora

Reg# 055192		Desloratadine 0.5mg/mLS.J. & G. Fazul Ellahie (PVT) Ltd., E-46, S.I.T.E., KarachiEthylene Glycol above the permissible limit
6.Inj. Isanex

Reg# 024657		Sterile Powder of Ceftriaxone Sodium
eq. to Ceftriaxone 1g/Vial		Humayun International Pharma (PVT) LTD 20-km, Satiana Road, Faisalabad“Substandard” with regards to Sterility Test
7.EmpLiMet XR tablet

Reg# 121679		Empaglifozin, Linagliptin, Metformic HClHorizon Healthcare (Pvt.) Ltd., Plot no. 33, sundar Industrial estate, LahoreSubstandard on the basis of Assay

Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

–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 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: Recall of 6 Batches of Neutrozole Infusion Manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore

    Muhammad Ayub Naveed Recall Alerts, Uncategorized

    Recall Alert

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    DRAP Alert NoNo I/S/11-24-51
    Action Date29th November, 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 Provincial Inspector of Drugs, Punjab collected the samples of Neutrozole Infusion from various districts of Punjab and sent for test / analysis. The Drugs Testing Laboratory, Multan has declared various batches the said product, manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore, as a Substandard product. The details of the case are as under:

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by
    Neutrozole Infusion 100ml
     
    Reg. No. 046878      		Metronidazole (500mg/100ml)Batch No. MZ023,
    MZ028,
    MZ010,
    MZ007,
    MZ006,
    MZ003    		M/s. Neutro Pharma (Pvt.) Ltd., 9.5 Km, Sheikhupura Road, Lahore-Pakistan.
    Risk Statement:Administration of products containing bacterial endotoxins through IV infusion may lead to complications, such venous thromboembolism, septic shock etc. which may have fatal consequences.
    Action Initiated-The manufacturer has been directed to immediately recall the defective batch of product from the market. The field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of the presence and removal of the mentioned batches from the market
    -The regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

    –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 by Email at gsms∂dra.gov.pk.

    –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
    Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

    -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the     Adverse Event Reporting Form or online through this link.

    -Please click here for further information on problem reporting to DRAP.
    Advice for Consumers-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

    -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

      Rapid Alert: Crackdown Against Falsified/Illegal Products

      Muhammad Ayub Naveed Product Recalls
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      Rapid Alert

      DRAP Alert NoNo I/S/11-24-45
      Action Date28th November, 2024
      Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
      ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
      ·        General Public
      Problem StatementDirectorate of Drugs Control (DDC) Punjab and Secretary PQCB Quetta have informed DRAP that samples of various products have been identified as spurious (falsified). Details of test reports are as under:

      S#Product NameCompositionBatch No.Manufactured by
      (as per label claim)      		Lab Test Results
      1
      Titan-1000 Injection

      Reg# 021743      		CeIftriaxone as Ceftriaxone Sodium 1000 mg/vial 22044Purported to be manufactured by Macter International Limited (as per label claim) F-216, S.I.T.E Karachi“Spurious” and “Substandard” with regards to Assay and Sterility test,
      Dyrone Film Coated Tablet

      Reg# 198069      		Dydrogesterone DR-121Purported to be manufactured by Solvay (as per label claim), Plot # 32, Sector,2 Highway Petaro Road Jamshoro SindhSpurious
      Solverone 10 mg Film Coated Tablet

      Reg# 068898      		DydrogesteroneSVN-001Purported to be manufactured by Solvay (Fictitious firm), Plot # 32, Sector,2 Highway Petaro Road Jamshoro SindhSpurious
      Dydowen 10mg Film Coated Tablet

      Reg# 101507      		Dydrogesterone736Purported to be manufactured by Weather Folds Pharmaceuticals, Hattar, Pakistan. Manufactured For: Wenovo Pharmaceuticals TaxilaSpurious
      DYDRO-FEM 10 mg Film CoatedTablet

      Reg# 555199      		DydrogesteroneDFD10/008
      DFD10/009      		Purported to be manufactured by
      Torrent Pharmaceutical, (as per label claim) G-19, Hawkesbay Road SITE, Karachi.      		Spurious
      M.CEF 30 mL Powder For Oral Suspension

      Reg# 0432189      		Cefixime as Trihydrate 100 mg/5mLD00018Purported to be manufactured by
      Dalton Laboratories PVT LTD. (as per label claim) Plot # G-149, Phase L-II Super Highway Road,
      S.I.T.E. LI Karachi      		Spurious
      Iodex Ointment

      Reg# 000394      		Iodine + MethylsalicylateHIAACPurported to be manufactured by GSK Pakistan KarachiCounterfeit
      (Falsified)
      Risk Statement:The impact of the use of falsified / Substandard products may lead to sub-optimal therapeutic effects whereas the use of a spurious product will lead to therapy failure or other associated problems.
      Action InitiatedThe field force under the administrative control of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for the detection of the presence and removal of the mentioned batches from the market.
      Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available on this link.

      Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link
      Advice for ConsumerConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using these 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: Recall of Substandard Flagynase Suspension (Reg. No. 087528) Batch No. 0362 Manufactured by M/s Aries Pharmaceuticals (Pvt.) Ltd, Peshawar

      Muhammad Ayub Naveed Recall Alerts

      Recall Alert

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      DRAP Alert NoNo I/S/11-24-49
      Action Date20th November, 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 Inspector of Drugs, Peshawar collected the samples of Flagynase Suspension and sent for test / analysis. The Central Drugs Laboratory, Karachi has declared batch No. 0362 of the said product, manufactured by M/s Aries Pharmaceuticals (Pvt.) Ltd, Peshawar, as a Substandard product.

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by
      Flagynase suspension
       
      Reg. No. 087528      		Metronidazole (200mg/5ml)Batch no. 0362
      Mfg date: 10/23
      Expiry date:
      10/25      		M/s. Aries Pharmaceuticals (Pvt.) Ltd., 1-W, Industrial Estate, Hayatabad, Peshawar. 
      Risk Statement:Metronidazole Oral Suspension is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or suspected. Use of substandard products may lead to suboptimal to no-therapeutic effects and may contribute to drug resistance, and can also intensify/exacerbate the existing bacterial infection.
      Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

      –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 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.

        DRAP Newsletter: Volume 03-Issue -II, November, 2024

        Asad Ullah General, Regulatory Updates

        The Drug Regulatory Authority of Pakistan (DRAP) has released a new issue of its quarterly newsletter, featuring several key updates and initiatives. DRAP has extended the scope of its Industry E-Reporting System for Adverse Drug Reactions to all registration holders, following a successful pilot project. The newsletter details recent actions on the promotion of clinical trials regulatory oversight, the stakeholder queries management system, and interprovincial coordination for the implementation of the Institutional Development Plan as per WHO recommendations. Additionally, the newsletter covers ongoing efforts to enhance public health and safety, including increased surveillance and regulatory actions to ensure the quality and safety of therapeutic goods.

        DRAP_NewsLtter_Nov2024Download

        Recall Alert: Recall of Nabaxo 10mg Film Coated Tablet Manufactured By M/s. Wenovo Pharmaceuticals, Taxila

        Asad Ullah Recall Alerts

        Recall Alert

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        DRAP Alert NoNo I/S/11-24-48
        Action Date15th November, 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 Senior Drug Inspector Islamabad has informed DRAP that batch number 263 of product namely Nabaxo 10mg film coated tablet has been declared as out of specifications by Drug Testing Laboratory Rawalpindi. Details of test reports are as under:

        Therapeutic Good(s) Affected: –

        Product NamesCompositionBatch DetailsManufactured by
        Nabaxo 10mg film coated tablet
         (Reg. No. 087751)        		RivaroxabanBatch No.263M/s. Wenovo Pharmaceuticals, Plot No. 31, 32, Punjab Small Industrial Estate, Taxila.
        Risk Statement:Nabaxo tablet contains Rivaroxaban is an anticoagulant medication used to treat and prevent blood clots. Rivaroxaban is used to treat deep vein thrombosis (blood clot, usually in the leg) and pulmonary embolism (blood clot in the lung) in adults. Substandard Rivaroxaban may lead to therapy failure in patients..
        Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

        –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 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.