The Food and Drug Administration (FDA) informs the public that the Toys and Childcare Articles (TCCA) product Coral Babies Water Filled Teether 3M+ with Notification No. 5000007475745, has been notified by the Market Authorization Holder, Coral Stone Corporation. in accordance with existing FDA rules and regulations.
Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. 2020-2194 and FDA Order No. 2020-1532 is hereby lifted.
The public is advised to always check if a Toys and Childcare Articles (TCCA) product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing. For more information or inquiries, please email us at [email protected]. You may also call the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research at telephone number (02) 8857-1900 loc. 8113 or 8117.
To report the sale or distribution of any unnotified/unregistered health products, kindly email FDA via [email protected].
Furthermore, 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 the existing laws, rules, and regulations.
Dissemination of this advisory to all concerned is hereby requested.