Events

Safety Alert for Treanda injection

According to Health Ministry (Panama), this safety alert involved a device in Panama that was produced by Teva Pharmaceuticals.

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
  • Date
    2015-06-09
  • Event Date Posted
    2015-06-16
  • Event Country
    Panama
  • Event Source
    HMP
  • Event Source URL
    http://www.minsa.gob.pa/informacion-salud/alertas-y-comunicados?title=&field_decree_date_value%5Bvalue%5D%5Byear%5D=2015&page=2
  • Notes / Alerts
    Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
  • Extra notes in the data
  • Reason
    The fda warns health professionals not to use treanda lnjection (45 mg i 0.5 ml or 180 mg i 2 ml solution) with closed system transfer devices (cctd), adapters and syringes containing polycarbonate or acrylonitrile- butadiene-styrene (abs). most commercialized cstds contain polycarbonate or abs and are not compatible with treanda injection (45 mg i 0.5 ml or 180 mg i 2 ml solution). n, n-dimethylacetamide (oma), an ingredient in treanda injection (45 mg i 0.5 ml or 180 mg i 2 ml solution), is incompatible with polycarbonate or abs. devices containing polycarbonate or abs dissolve when they come into contact with oma. this can lead to device failure, possible product contamination and possible serious adverse health consequences, including skin reactions in health professionals who prepare and administer this product; and the risk of small obstruction of blood vessels in patients.

Device

Treanda injection

Manufacturer

Teva Pharmaceuticals