Events

Safety Alert for SURE-GEL (Acidulated Phosphated Fluoride)

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by N/A.

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 Number
    2018-100
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/497498-fda-advisory-no-2018-100
  • Notes / Alerts
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 Philippines.
  • Extra notes in the data
  • Reason
    Fda advisory no. 2018-100 public  health  warning  against  the   purchase  and  use  of   unregistered  medical   device  sure-gel (acidulated phosphated fluoride) the food and drug administration (fda) hereby advises the public against the purchase and use of the product sure-gel (acidulated phosphated fluoride) whose  particular/details are  provided below:   name of product   name of manufacturer/importer and distributor   status of registration   sure-gel (acidulated phosphated fluoride)   not indicated   unregistered fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of certificate of product registration. pursuant to republic act no. 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited. in this regard, the public is hereby advised not to purchase and use the above-mentioned product  and to be vigilant against the medical device products that are not registered with the fda. all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that these products are not sold in any market. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and development division – center for device regulation, radiation health and research of the fda at telephone no. (02) 857-1900 loc. 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-100.Pdf.

Device

SURE-GEL (Acidulated Phosphated Fluoride)
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP