Events

Safety Alert for Iodent Denture Cleanser, Iodent Denture Cleansers Overnight Whitening

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
    2017-183
  • 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/440485-fda-advisory-no-2017-183
  • 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. 2017-183 public health warning against the use of unregistered medical device products “iodent denture cleanser and iodent denture cleansers overnight whitening” the food and drug administration (fda) advises the public against the use of the unregistered medical device products iodent denture cleanser (20 tablets) and iodent denture cleansers overnight whitening (18 tablets): post-marketing surveillance activities conducted by the fda have verified that the abovementioned medical device products has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration. pursuant to the provisions of republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from fda is prohibited. the abovementioned products did not undergo the evaluation process of the fda. thus, the agency cannot guarantee its quality and safety. in this regard, the public is hereby advised not to purchase the above-mentioned violative products. all concerned establishments are warned not to advertise, sell or distribute the said products until such have been issued with the corresponding certificate of product registration, otherwise, regulatory actions and sanctions shall be strictly pursued. all local gocvernemnt units (lgus) and law enforcement agencies (leas) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction. 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. 2017-183.Pdf.

Device

Iodent Denture Cleanser, Iodent Denture Cleansers Overnight Whitening
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP