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Year: 2024

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.

      Rapid Alert: Crackdown Against Falsified/Illegal Products

      Asad Ullah Recall Alerts
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      Rapid Alert

      DRAP Alert NoNo I/S/11-24-44
      Action Date08th November, 2024
      Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
      ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
      ·        General Public
      Problem StatementThe Directorate of Drugs Control (DDC) Punjab has identified the following falsified products in the market. The samples of these products were also analyzed by provincial Drug Testing Laboratories in Punjab. The details of the identified products are as under:

      S#Product NameCompositionBatch No.Manufactured by
      (as per label claim)      		Lab Test Results
      1Ativan 2mg Tablets

      Reg# 000084       		Lorazepam  17C7019Purported to be manufactured by Pfizer Pakistan Ltd, Karachi PakistanSpurious
      2Klozen 5 mL Eye Drops

      Reg# 040124      		Tobramycin 0.3%, Dexamethasone 0.1%134Purported to be manufactured by Zinta Pharmaceutical Industry, Hayatabad, PeshawarSpurious
      3S-Kyne 10mg Tablets

      Reg# Nil      		Dydrogesterone566Purported to be manufactured by Weather Folds pharmaceuticals, HattarSpurious & Misbranded
      4Efaston 10mg Tablets

      Reg#  31067      		Dydrogesterone064835Purported to be Manufactured by Lahore Chemical & Pharmaceutical Works (Pvt) Ltd. LahoreSpurious
      5Dydowen 10mg Tablets

      Reg# 101507       		Dydrogesterone462Purported to be Manufactured by Weather Folds Pharmaceuticals, HattarSpurious
      6Phenobar 30mg Tablets

      Reg# 018862      		PhenobarbitoneQA030Purported to be Manufactured by Star Laboratories (Pvt) Ltd (Human Healthcare Division) 23-KM Multan Road LahoreSpurious
      7Duphaston 10mg Tablets

      Reg# 006654      		Dydrogesterone230672Purported to be Manufactured by Highnoon Laboratories Ltd. Marketed by Abbot Laboratories (Pakistan) Ltd, LahoreSpurious
      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.

      Rapid Alert: Recall of 04 Batches of Drug Products from Market

      Asad Ullah Recall Alerts
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      Rapid Alert

      DRAP Alert NoNo I/S/11-24-45
      Action Date08th November, 2024
      Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
      ·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
      ·         Veterinary Healthcare Professionals
      ·  General Public
      Problem StatementDirectorate of Drugs Control (DDC) Punjab has informed DRAP that samples following products have been analyzed by the provincial DTLs in Punjab and have been declared as substandard due to reasons mentioned below. The detail of affected products is as under:

      S#Product NameCompositionBatch No.Manufactured byTest Results  
      01Nida Infusion 100ml   Reg. No. 079630Metronidazole 500mg/100ml  23E317GMP Pharmaceuticals, 28-Km Sheikhupura Road,  Lahore.Substandard due to visible particles and Bacterial Endotoxin.
      02Metroin Infusion 100ml   Reg. No. 071279Metronidazole 500mg/100ml  MT24-055Saturn Pharmaceuticals, 23-Km, thokar Raiwind Road, LahoreSubstandard due to presence of visible particles.
      03Tylosan 20 Injection 100ml   Reg. No. 027416 (For vet use only)Tylosin base 200mg/ml  TS-259Sanna Laboratories, 1019-B, P.I.S.E., Sargodha road, Faisalabad.Substandard due to presence of visible particles.
      04Melacam-10 injection 50ml   Reg. No. 063542 (For vet use only)Meloxicam 10mg/ml  23U-03Medi-vet (Pvt) Ltd., 17-Km Sheikhupura road, LahoreSubstandard on the basis of visible particles and extractable volume.
      Threat to Public HealthAdministration of products containing visible solid particles and/or bacterial endotoxins through IV infusion may lead to complications, such venous thromboembolism, septic shock etc.  which may have fatal consequences.
      Action InitiatedThe manufacturing companies of these products have been directed to immediately recall the affected batches of their products from the market. The Regulatory Field Force of DRAP and Provincial Drug Control Administrations have been directed to conduct market surveys for monitoring the recall process to ensure effective removal of defective batches from the market.

      All 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) should have increased surveillance in the market to ensure the effective recall of defective products(s).
      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 of 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.