Events

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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by American Pharmaceutical Peçasners Inc.

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
    212
  • Date
    2000-11-24
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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.
  • Action
    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