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Rapid Alert: CRACKDOWN AGAINST FALSIFIED PRODUCTS

Muhammad Ayub Naveed Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/12-24-56
Action Date31st December, 2024
Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
3. General Public
Problem StatementThe Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples of various products have been identified as spurious (falsified). Details of test reports are as under:

The product identification details are as under:

Therapeutic goods affected:

ProductBatch No*Mfg DateExp. DateManufacturer Name
(as per label)		Remarks
S-KYNE Film Coated Tablet
(Dydrogesterone 10mg)
Reg# 100245		566––Purported to be manufactured by
Weather Fold Pharmaceuticals, 69/2 Phase-II, Industrial Area, Hattar		Spurious and Misbranded
MY-RON film coated tablet
(Dydrogesterone 10mg)
Reg# 119670		MYR-001––Purported to be manufactured by Piriv Pharmaceutical, (Fictitious firm), 69-Km, Multan Road, LahoreSpurious
Syrup Carenol 60ml
(Ammonium Chloride 125mg, Sodium Citrate 55mg, Chlorpheniramine Maleate 205mg/5ml)
Reg# 026907		CL-037––Purported to be manufactured by Well Care Pharmaceuticals, A/7, P.S.I.E, SargodhaSpurious and Misbranded
Syrup Histacare 450ml
(Chlorphineramine Maleate) 2mg/5ml
Reg# 066498		HE-036––Purported to be manufactured by Well Care Pharmaceuticals, A/7, P.S.I.E, SargodhaSpurious
Syrup Trylac 120 mL
(Lactulose 66.7g/100 mL)
Reg# 0543511		TL-113––Purported to be manufactured by
Torrent Pharmaceuticals (Fictitious Firm) G-19, Hawkes Bay Road, SITE, Karachi		Spurious and Misbranded
Capsule Emmox 500 mg
(Amoxicillin 500mg)
Reg# 9440494		010527––Purported to be manufactured by Milpharma Int’l Ltd, (Fictitious Firm) D-40 KarachiSpurious
Vital Wal injection 100ml
(Vit. A 60000IU, Vit. D3 40000IU,
Vit. E 20mg)
Reg# 000735)		1-109––Purported to be manufactured by Nawal Pharmaceuticals, Plot No. 11-A, Punjab Small Industrial Estate, TaxilaSpurious

Action InitiatedAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying the mentioned products. The remaining stocks 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). DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of the mentioned products. Adverse reactions or quality problems experienced with the use of these products are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.  Further information of reporting problems to DRAP is available on this link.
Advice for Therapeutic Goods ManufacturersAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products.

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 at this link.
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.

Recall Alert: Recall Notices Issued by Provincial Drug Testing Laboratories

Muhammad Ayub Naveed Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/12-24-57
Action Date31st December, 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 DDCP PV Lahore and Secretary PQCB Quetta have informed DRAP regarding the recall of the following batches of the mentioned products:

Therapeutic Good(s) Affected: –

Sr.No.Product NamesCompositionManufactured byTest Results
1.Injection I-Vitamin Super 100ml
(FOR VET USE ONLY)

Reg# 062066		Each ml contains: sodium Selenite 0.5mg, Vit. E 70mg, Vit. B12 0.1mg, Vit. B1 20mg, Adenosine-5 Monophosphate 5mg

Batch Number 6501		International Pharma Labs, Raiwind Road, Bhobtian Chowk, Defence road, 1Km towards Kahna, LahoreAdulterated and Substandard
2.Injection Oxytocin 50ml
(FOR VET USE ONLY)

Reg# 020830		Oxytocin 10IU/ml

Batch Number OXY-2219		Lawrance Pharma (Pvt.) Ltd., 10.5 Km Shekhupura road, Lahore.Substandard
3.Injection Flagyl 100ml

Reg# 005102		Metronidazole 500mg/100ml

Batch Number AD354		Sanofi-Aventis Pakistan Limited,
Plot no. 23, Sector 22, Korangi Industrial Area, Karachi		Substandard
4.Capsule Esopase 20mg

Reg# 045914		Esomeprazole 20mg

Batch Number 3K159		Lucky Core Industries Ltd., 32/2A, Phase 3, Industrial Estate HattarSubstandard

Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have been requested to immediately conduct market surveys for detection and removal of these products from the market.

–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.
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 Substandard Folic Acid Tablet Batches (490, 612) Manufactured By M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi.Recall Alert:

    Muhammad Ayub Naveed Uncategorized

    Recall Alert

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    DRAP Alert NoNo I/S/12-24-56
    Action Date18th December, 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 of various districts of Balochistan collected the samples of Folic acid Tablet and sent for test / analysis. The Drug Testing Laboratory, Quetta has declared following batches of Folic acid Tablet, manufactured by M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi, as of substandard quality based on uniformity of weight:

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by
    Tablet Folic Acid
    Reg. No. 000859    		Folic acid 5 mgBatch No. 490
    Batch No. 612    		M/s. Zafa Pharmaceutical Laboratories (Pvt.) Ltd. 4/1, A&B, Block-21, Federal “B” Industrial Area, Karachi-75950 
    Risk Statement:Folic Acid Tablets not complying with the uniformity of weight specification could result in inconsistent dosages of the active pharmaceutical ingredient (API), potentially leading to reduced therapeutic efficacy or an increased risk of adverse effects 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 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: Substandard Dexyken 300 mg Tablet Batch No. Kf23006  Manufactured By M/s. Kanel Pharma, Plot 6, Street SS-3, Rawat Industrial Estate, Islamabad

      Muhammad Ayub Naveed Recall Alerts, Uncategorized

      Recall Alert

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      DRAP Alert NoNo I/S/12-24-55
      Action Date12th December, 2024.
      Target Audience– National Regulatory Field Force.
      – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
      – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
      – General Public
      Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. KQ-9-24-000142 has declared the subject mentioned batch of product Dexyken 300mg tablet as of substandard quality. Details of CDL test report are as under:

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by
      Dexyken Tablet

      Reg# 075234      		Dexibuprofen 300 mgBatch no. KF23006
      Mfg date: 06/2023
      Expiry date:
      06/2025      		M/s. Kanel Pharma, Islamabad
      Risk Statement:Dexibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce inflammation and pain in conditions such as arthritis. The identified quality issue with these tablets may result in Reduced Efficacy, depending on the degree of substandard quality and the patient’s condition. Vulnerable populations, including elderly patients and those with existing gastrointestinal, cardiovascular, or renal conditions, may be at a higher risk.
      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: Substandard Nocox Tablets Batch No. 8463 Manufactured by M/s. Alfalah Pharma (Pvt.) Ltd., 12-Km Lahore Road, Jamal Park, Sheikhupura

        Muhammad Ayub Naveed Recall Alerts

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        DRAP Alert NoNo I/S/12-24-54
        Action Date12th December, 2024.
        Target Audience– National Regulatory Field Force.
        – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
        – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
        – General Public
        Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. LHR-10-24-000007 has declared the subject mentioned batch of product Nocox tablet as of substandard quality. Details of CDL test report are as under

        Therapeutic Good(s) Affected: –

        Product NamesCompositionBatch DetailsManufactured by
        Nocox Tablet

        (Reg# 052499)        		Meloxicam 15mgBatch no. 8463
        Mfg date: 02/2024
        Expiry date:
        02/2026        		M/s. Alfalah Pharma (Pvt.) Ltd., 12-km Lahore Rd, Jamal Park, Sheikhupura
        Risk Statement:Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce inflammation and pain in conditions such as arthritis. The identified quality issue with these tablets may result in Reduced Efficacy, depending on the degree of substandard quality and the patient’s condition. Vulnerable populations, including elderly patients and those with existing gastrointestinal, cardiovascular, or renal conditions, may be at a higher risk.
        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.

          Rapid Alert: Contaminated Propylene Glycol (Batch # YF01210911) Allegedly Manufactured by M/S. Dongying Hi-Tech Spring Chemical Industry Co. Ltd., China.

          Muhammad Ayub Naveed Recall Alerts
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          Rapid Alert

          DRAP Alert NoNo  I/S/12-24-52
          Action Date12th December, 2024
          Target Audience1. Regulatory Field Force.
          2. Therapeutic Goods industry
          3. Manufactures of Oral liquid preparations
          4. Healthcare professionals
          Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No. RM-10-24-000624 dated 19-11-2024 declared the sample of Propylene Glycol (Raw material) sent to CDL Karachi by a licensed pharmaceutical manufacturer in compliance to advisory issued by DRAP vide No. 03-41/2023-QC dated 01-12-2023. The supply chain of this raw material is still under investigation. Details of test/analysis report are given as under:

          The product identification details are as under: –

          Therapeutic Good Affected:-

          ProductBatch No*Mfg DateExp. DateManufacturer Name
          (as per label)          		Remarks
          Propylene Glycol
          (Raw material)          		YF0121091122-May-202321-May-2025M/s. Dongying Hi-Tech Spring Chemical Industry Co. Ltd., China.[The material found in the packaging with the label of this manufacturer, however product authenticity and supply chain integrity are under investigation and yet not confirmed.]The sample is declared substandard
          due to conatmination of Ethylene Glycol.

          Risk StatementDi-Ethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
          Action InitiatedThe Regulatory Field Force has directed to take increase surveillance for identification of above mentioned contaminated batch of Propylene Glycol in the market and is investigating the entire supply chain of this batch. The Regulatory Field Force has also been instructed to seize all oral preparations manufactured using the same batch of propylene glycol if found in the market.
          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 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 the same lot of propylene glycol should be kept on hold. 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.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.
          5.      Follow Guidelines: Adhere to the pharmacopoeia 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 : Falsified Product Askinoren Gel (Azelaic Acid 15%) Purportedly Manufactured By M/s. Medshare Pharma Risalpur, Kpk

          Muhammad Ayub Naveed Recall Alerts
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          Rapid Alert

          DRAP Alert NoNo I/S/12-24-56
          Action Date10rd December, 2024
          Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
          ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
          ·        General Public
          Problem StatementThe firm M/s OBS Pharma (Pvt.) Limited, Karachi, has notified DRAP regarding the presence of falsified product “Askinoren Gel” in the market across Pakistan.  The primary packaging of the product shows no Batch number and Expiry date. Also, a different brand name Acnoren was mentioned under the heading of dosage. Moreover, there was no Urdu instruction and dosage required as per Labelling Rules, 1986. The details of the identified product are as under:

          S#Product NameCompositionBatch No.Manufactured by
          (as per label claim)          		Lab Test Results
          1Askinoren GelAzelaic Acid 15%)NilM/s Medshare Pharma, Plot No. 04, Special Industrial Zone (APO) Risalpur, KPK.Spurious
          Risk Statement:Azelaic acid is used for the treatment of skin pigmentation and acne. Falsified product may pose a significant threat to public health as the safety and efficacy of such products cannot be established.
          Action InitiatedThe Regulatory Field Force has been directed to take necessary action on the above-mentioned falsified product and is investigating the entire supply chain of this product. The Regulatory Field Force has also been instructed to seize identified falsified products if found on 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 at this link.

          Any adverse events or quality problems experienced with the use of these products should be reported to the 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.

          Rapid Alert: Falsified Dayquil Kids (Vicks) Berry Cold & Cough + Mucus Purportedly Manufactured By M/S. Procter & Gamble, Cincinnati, OH 45202.

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          Rapid Alert

          DRAP Alert NoNo I/S/12-24-51
          Action Date03rd December, 2024
          Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
          ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
          ·        General Public
          Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No. KQ-7-24-000112 dated 15-10-2024 declared the sample of DayQuil Kids (Vicks) as unregistered (Falsified) Drug. The product contains Dextromethorphan HBr which is an allopathic drug, therefore, the said product must be registered with DRAP. The details of the product are as under:

          S#Product NameCompositionBatch No.Manufactured by
          (as per label claim)          		Lab Test Results
          1DayQuil Kids (Vicks) Berry Cold & Cough + MucusNil31254334L4Purported to be manufactured by M/S.PROCTER & GAMBLE, CINCINNATI, OH 45202Spurious
          Risk Statement:DayQuil Kids (Vicks) is a widely available over-the-counter (OTC) medication for cough and flu relief. However, its active ingredient, Dextromethorphan HBr, may pose potential health risks, necessitating regulatory oversight to ensure safe consumption.
          Action InitiatedThe Regulatory Field Force has been directed to take necessary action on the above-mentioned falsified product and is investigating the entire supply chain of this product. The Regulatory Field Force has also been instructed to seize identified falsified products if found on 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 at this link.

          Any adverse events or quality problems experienced with the use of these products should be reported to the 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 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.