GMPc Vietnam JSC
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Thu hồi kháng sinh và vaccine kém chất lượng

02/06/2016 | 4245 | Tin tức Tổng hợp

Ngày 31-3, ngay sau khi nhận được báo cáo của Viện Kiểm nghiệm thuốc trung ương về kết quả kiểm nghiệm mẫu thuốc viên nang cứng Cadicefpo 200 (Cefpodoxime 200mg), số lô: 080915, NSX: 9-10-2015, HD: 9-10-2018, SĐK: VD-13350-10 do Công ty TNHH US Pharma USA sản xuất không bảo đảm chất lượng về chỉ tiêu độ hòa tan, Cục Quản lý dược, Bộ Y tế đã quyết định chỉ lưu hành và thu hồi toàn bộ lô thuốc này trên phạm vi toàn quốc.
 

Đồng thời, Cục Quản lý dược yêu cầu Công ty TNHH US Pharma USA phối hợp với nhà phân phối khẩn trương gửi thông báo thu hồi đến các cơ sở bán buôn, bán lẻ, sử dụng lô thuốc này và báo cáo Bộ Y tế trước ngày 4-4-2016. Được biết, thuốc viên nang cứng Cefpodoxime là một loại kháng sinh được dùng dưới dạng uống để điều trị các bệnh từ nhẹ đến trung bình ở đường hô hấp dưới, kể cả viêm phổi cấp tính mắc phải ở cộng đồng.

Cùng với đó, Cục Quản lý dược cũng quyết định đình chỉ lưu hành trên toàn quốc vaccine ngừa dại Lyssavac N có các lô như sau: Số lô Ro 107, HSD: tháng 4-2017; số lô: RO 114, HSD: tháng 6-2017; số lô: RO 117, HSD: tháng 6-2017. Đây là loại vaccine do Công ty Cadila Heathcare, Ấn Độ sản xuất, Công ty cổ phần Xuất nhập khẩu y tế TPHCM (Yteco) nhập khẩu, Công ty cổ phần vaccine và sinh phẩm Nam Hưng Việt nhập khẩu ủy thác.

Cục Quản lý dược yêu cầu công ty nhập khẩu và nhập khẩu ủy thác phải gửi thông báo thu hồi tới tất cả các cơ sở sử dụng vaccine, tiến hành thu hồi toàn bộ lô vaccine còn lại. Đồng thời, báo cáo về Bộ Y tế số lượng vaccine Lyssavac N đã nhập khẩu, mua bán và sử dụng.
 
NGUYỄN QUỐC
 

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  • GMPc Vietnam JSC
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  • Home
  • About Us
    • Summary information
    • Key Personnel
  • Services
    • WHO GMP Pharmaceutical facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • EU GMP Pharmaceutical Factory
      • Feasibility study report
      • Design detailed construction drawings
      • QM documentation – Validation
      • GMP application and product dossier application
      • Project management - Construction supervision
    • CGMP, ISO 22716-certified cosmetics facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • CGMP ASEAN Training and Guidance
      • Preparation of CGMP ASEAN/ ISO 22716 registration dossier
      • CGMP ASEAN Re-evaluation consultation
    • Health-supplement facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • HS GMP Training and Guidance
      • Preparation HS GMP registration dossier
      • HS GMP - Re-evaluation consultation
    • Eligibility For Cosmetic Manufacturing
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • Pharmaceutical distribution center
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • GSP warehouses
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Veterinary Pharmaceutical Facilities
      • Project Feasibility Study
      • Technology and Equipment consultation
      • Detail Construction and MEP Drawing
      • Project management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • GMP, GLP, GSP training
      • Basis knowledge
      • Intensive Training
    • Other GPs’s consultation
      • GLP inspection laboratories
      • GDP distribution systems
      • GPP pharmacy
      • WHO GACP medicinal materials
    • Register and Announce
      • Announcement of Imported Cosmetic
    • Dairy Factory
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
  • Jobs
  • Contact
 
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