Events

Alerta De Seguridad para 61% USP Iopamidol-300 150 ml bottle. Single-dose 200 ml Injection Bottles.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por American Pharmaceutical Peçasners Inc.

¿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
  • ID del evento
    211
  • Fecha
    2000-11-24
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The vials mentioned have been removed because of their lack of effect. the manufacturer initiated the recall through correspondence sent on september 21, 2000. the company did not provide any information to ecri.
  • Acción
    Make sure you received the September 21 correspondence from American Pharmaceutical Partners. Identify and collect any affected product from your inventory. Contact the manufacturer for refund or replacement of affected products. For more information contact your local manufacturer's representative, American Pharmaceutical Partners

Device

61% USP Iopamidol-300 150 ml bottle. Single-dose 200 ml Injection Bottles.

Manufacturer

American Pharmaceutical Peçasners Inc
  • Source
    ANVSANVISA