If you happen to have bought or kept a bottle of Sangobion Kids Iron + Vitamin B Complex syrup, do not give it to your child for consumption.
The imported product has been voluntarily recalled by its marketing authorization holder (MAH), according to an advisory issued by the Food and Drug Administration (FDA) of the Philipines.
The recall is "due to the detection of ethylene glycol above the the maximum allowable limit which may elicit potential adverse reactions if consumed in high doses."
Ethylene glycol is an industrial compound used in many consumer products, such as antifreeze, hydraulic brake fluids, some stamp pad inks, ballpoint pens, solvents, paints, plastics, films, and cosmetics.
The FDA advisory relayed the report of the MAH that product retrieval from the distributors and consumer are still ongoing.
Some 135,027 bottles out of the total 426,756 imported Sangobion Kids syrup were already put on hold in the MAH’s distributor warehouse, as of January 5, 2023.
Additionally, 234 drug distributor/retailers out of 445 confirmed that they have retrieved 34,660 bottles and therefore no longer in stores. The product's manufacturer has also started investigating the matter.
The FDA advisory shared the collated reports from the product's MAH and consumers alike on the adverse drug reaction caused by the vitamin syrup, as of January 9, 2023.
Leading the list are vomiting, diarrhea, decreased appetite, pallor, and abdominal pain. But none reported any fatal or life-threatening outcomes.
The product's distributors, hospitals, retailers, pharmacies, or clinics that have stocks of the product are therefore instructed by the FDA to discontinue further distribution, sale, and use.
If you have purchased Sangobion Kids syrup, you may contact Procter & Gamble (P&G) 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.
In case of ingestion of the product and your child experienced any of the adverse reactions, seek immediate medical attention.
You also need to contact the following channels:
- National Poison Management and Control Center at (02) 8524 1078 (PLDT), or +63 966 718 9904 (Globe), or Fax: 02-526
- P&G Consumer Care contacts
- FDA at https://primaryreporting.who-umc.org/Reporting/Reporter
- Center for Drug regulation and Research at the telephone number (02) 88095596
Read here on the topic of vitamins for kids.
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