Events

Alerta De Seguridad para Ventolin Inhaler 100 mcg

Según National Drugs Administration from El Salvador (DNM), este evento ( alerta de seguridad ) involucró a un dispositivo médico en El Salvador que fue producido por GLAXO WELLCOME S.A.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Clase de Riesgo del Evento
    Class I
  • Fecha
    2018-04-10
  • País del evento
    El Salvador
  • Fuente del evento
    DNM
  • URL de la fuente del evento
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    - 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.
  • Acción
    - 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
  • Modelo / Serial
    Registration number: F009302022000; Lot number: A22M
  • Manufacturer
    GLAXO WELLCOME S.A

Manufacturer

GLAXO WELLCOME S.A