The Food and Drug Administration (FDA) warned the public on Thursday, Dec. 7, against the purchase and use of an unregistered antiseptic disinfectant that has not undergone its evaluation process.
FDA identified the unregistered drug product that is considered “not safe" as “Agua Oxigenada F.E.U. XIV-10 Vols 120 ml.”
It emphasized the drug has not undergone the FDA's evaluation process and lacks proper authorization in the form of a Certificate of Product Registration.
Post-marketing surveillance activities by the FDA have confirmed the absence of the drug's registration, raising concerns about its quality and safety.
Pursuant to Republic Act No. 9711, also known as the "Food and Drug Administration Act of 2009," the agency stated that the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising, or sponsorship of health products without proper FDA authorization is strictly prohibited.
All concerned establishments and entities are strongly advised against distributing the aforementioned violative drug product until it receives the appropriate authorization.
Failure to comply may result in regulatory actions and sanctions, the FDA noted.
The FDA calls upon local government units and law enforcement agencies to ensure that the unregistered product is not sold or made available within their localities or areas of jurisdiction.