The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that Outshine Philippines Inc., the distributor of Med Guard Cotton Balls and Med Guard Pure and Absorbent Cotton had complied with the FDA rules and regulations. The said establishment removed the claims that these products are intended for medical use.
Accordingly, the warning against the purchase and use of the abovementioned products as mentioned in FDA Advisory No. 2022-1586 dated 06 September 2022 is hereby lifted.
The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected] or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of unnotified medical device, contact the online reporting facility, eReport, through e-mail at [email protected].
Dissemination of this advisory to all concerned is hereby requested.