13/01/2023
FDA PRESS STATEMENT | 11 January 2023
UPDATES ON THE VOLUNTARY RECALL OF SANGOBION KIDS SYRUP
The Food and Drug Administration (FDA) issued FDA Advisory No. 2022-1968 on the voluntary recall of Iron + Vitamin B Complex [Sangobion Kids] Syrup due to the detection of ethylene glycol above the maximum allowable limit which may elicit potential adverse reactions if consumed in high doses.
As reported by the Marketing Authorization Holder (MAH), product retrieval from the distributors and consumer are still ongoing. As of 05 January 2023, 135,027 bottles out of the total 426,756 imported Sangobion Kids Syrup were already put on hold in the MAH’s distributor warehouse. In addition, 234 drug distributor/retailers out of 445 confirmed that 34,660 bottles are on hand and already off-shelves. Also, the investigation conducted by the manufacturer is still in progress.
Furthermore, the FDA received 18 adverse drug reaction (ADR) reports from consumers and MAH as of 09 January 2023. The top reported ADRs are vomiting, diarrhea, decreased appetite, pallor and abdominal pain. None of the reports resulted to fatal/life-threatening outcomes.
Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have stocks of the product are instructed to discontinue further distribution, sale, and use. Likewise, all consumers are advised not to use or purchase Sangobion Kids Syrup. If you have purchased the subject product, you may contact Procter & Gamble Philippines, Inc. at 88943955 (Metro Manila) or 1800 1888 8008 (Outside Metro Manila) for guidance on return and refund, and for any question or additional information regarding the recall.
If your child has consumed Sangobion Kids Syrup and experienced adverse reactions including but not limited to the abovementioned reactions, please contact the National Poison Management and Control Center at (02) 8524 1078 (PLDT), or +63 966 718 9904 (Globe), or Fax: 02-526, seek urgent medical attention and please report to the P&G Consumer Care contacts above.
Any suspected adverse reaction experienced from the use of the product should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields. You may also call the Center for Drug regulation and Research at the telephone number (02) 88095596.
