Events

Safety Alert for Napid Fluor

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Prodont Scientific Ltda.

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
    I1611-509
  • Event Number
    2009DM-0003388
  • Date
    2016-11-10
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=114
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer informs that it has detected a case of falsification of its product in the city of villavicencio, marketed in plastic drippers labeled "napid fluor / whiter teeth, chewing gum flavor" and using the manufacturer's data and the sanitary registry of the original product, in addition the manufacturer he affirms that the product in mention is of dental use.

Device

Napid Fluor
  • Model / Serial
    NAPID FLUOR acid with flavor and color
  • Product Description
    Topical prophylactic treatment against dental caries.
  • Manufacturer
    Prodont Scientific Ltda

Manufacturer

Prodont Scientific Ltda
  • Source
    NIDFSINVIMA