Events

Ventolin Inhaler 100 mcg 의 안전성 경고

National Drugs Administration from El Salvador (DNM)에 따르면, 해당 안전성 경고 는 El Salvador 에서 GLAXO WELLCOME S.A 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 위험등급
    Class I
  • 날짜
    2018-04-10
  • 사례 국가
    El Salvador
  • 사례 출처
    DNM
  • 사례 출처 URL
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • 비고 / 경고
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and El Salvador.
  • 데이터 추가 비고
  • 원인
    - the aforementioned product was investigated, confirming that it does not correspond to the one legitimately manufactured by gsk, presenting difference in the placement of the texts, difference in the barcode, difference in the device, difference in the insert, difference in the watermark in the safety labeling and in the inhaler bottle, the expiration date which does not correspond to the life time of the product. the product can be recognized by consigning the lot number a22m and expiration date june 2019. - the conditions of manufacture and packaging, the qualitative formula, the quality of the raw materials used and the finished product are unknown. - include within the list of falfra.
  • 조치
    - Notice to the population not to consume the product and inform the National Drugs Administration about the commercialization, distribution or dispensing of this product within any pharmaceutical establishment. - Perform searches of the product in the BAPs or routine searches. - To find the product in existence within the country, a national alert will be issued.

Device

Ventolin Inhaler 100 mcg
  • 모델명 / 제조번호(시리얼번호)
    Registration number: F009302022000; Lot number: A22M
  • Manufacturer
    GLAXO WELLCOME S.A

Manufacturer

GLAXO WELLCOME S.A