Metro Manila (CNN Philippines, January 13) — Eighteen children have reportedly experienced adverse reactions after taking Sangobion iron and vitamin B-complex syrup which has been recalled from the market, the Food and Drug Administration (FDA) said.
In a press release dated Jan. 11, the FDA said the count was as of Jan. 9, and the top reported adverse drug reactions (ADR) were vomiting, diarrhea, decreased appetite, pallor and abdominal pain.
None were fatal or life-threatening cases, it noted.
Earlier, the agency announced that all batches of the Sangobion Kids “Iron + Vitamin B-Complex” syrup are being voluntarily recalled from the market due to the detection of ethylene glycol above the maximum allowable limit, which may elicit potential adverse reactions if consumed in high doses.
The manufacturer has yet to conclude its investigation on the matter, according to the FDA. It added that product retrieval from distributors and consumers is also still in progress.
As of Jan. 5, the FDA reported that 135,027 bottles out of the total 426,756 imported Sangobion Kids syrup were already put on hold in the Marketing Authorization Holder’s distributor warehouse.
Meanwhile, 234 out of 445 distributors or retailers confirmed that 34,660 bottles are “on hand and already off-shelves.”
The FDA reiterated its instruction to distributors, retailers, hospitals, pharmacies, clinics, and consumers to immediately stop the distribution, sale, and use of the product.
Parents or guardians are also instructed to do the following should they suspect adverse reaction from kids after intake of the multivitamins syrup:
– Contact the National Poison Management and Control Center at (02) 8524 1078 (PLDT), or +63 966 718 9904 (Globe), or Fax: 02-526.
– Report the adverse reaction to the FDA, and to Procter & Gamble Philippines through the telephone number 88943955 (Metro Manila) or 1800 1888 8008 (outside Metro Manila).
– Seek urgent medical attention.
The FDA added that consumers may also call the Center for Drug Regulation and Research at (02) 88095596 for suspected ADR cases.
Meanwhile, those who have bought the product may return it and ask for a refund by contacting Procter & Gamble through the previously aforementioned numbers of the company.
