The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:
- Methyl Salicylate (Oil of Wintergreen) 25mL
- Ap-Ap Solution 3% solution 15mL
- EPHIC Gentian Violet 1% Solution 15mL
- EPHIC Eucalyptus Oil 15mL
- EPHIC Salicylic Acid 3% Solution
- Hydrogen Peroxide (Agua Oxigenada Solution) 60mL
- Povidone Iodine (Povidine 10% Solution) 15mL
- Ethyl Alcohol (70% Solution Electro Rubbing Alcohol Antiseptic Disinfectant With Moisturizer) 180mL
FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.
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, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.
In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.
All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
All Local Government 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 e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.
Dissemination of the information to all concerned is requested.
Attachment:-> FDA Advisory No.2020-241