Events

Safety Alert for Ultra Gel Ultra, Registration nº 80316110001, Lot: 299/13

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Multigel Indústria e Comercio, Importação e Exportação de Produtos para a Saude Ltda-EPP.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1418
  • Date
    2014-09-08
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    The company should trigger product recall action.
  • Reason
    According to the single sample tax review report 851.00 / 2014, issued by the adolfo lutz institute, ultra gel ultra product, val. 05/2015, lot 299/13, was considered unsatisfactory in the aspect test with presence of particles in and adhered to the inner wall of the bottle.
  • Action
    Resolution RE No. 3,380 of September 2, 2014 determined, as a measure of health interest, the suspension of distribution, trade and use, as well as the collection, throughout the national territory, of the product Ultra Gel Ultra, Val. 05/2015 , lot 299/13.

Device

Ultra Gel Ultra, Registration nº 80316110001, Lot: 299/13

Manufacturer

Multigel Indústria e Comercio, Importação e Exportação de Produtos para a Saude Ltda-EPP
  • Source
    ANVSANVISA