MANILA (UPDATE) – P&G Philippines on Tuesday said it is conducting a voluntary recall of Sangobion Kids 100 ml (Iron + Vitamin B-Complex in the country due to “the potential presence of ethylene glycol above the allowable limits in a raw material.”
The recall was initiated following a consultation with the Philippine Food and Drug Administration (FDA), P&G Philippines said in a statement.
Sangobion Kids 100 ml is used for the treatment and prevention of iron deficiency anemia (IDA) in children, latent insufficiency of iron and vitamin B during the growth period, and iron deficiency after loss of blood.
According to the US Centers for Disease Control and Prevention, ethylene glycol is found in many consumer products such as hydraulic brake fluids, some stamp pad inks, ballpoint pens, solvents, paints, plastics, films, and cosmetics.
The US CDC said ethylene glycol breaks down into toxic compounds in the body.
P&G said the recall is limited to Sangobion Kids 100 ml sold in the Philippines. Those sold in other countries are not impacted by the recall, the company said. No other Sangobion products are affected.
“We decided to take precautionary measures including the voluntary recall of all batches of Sangobion Kids 100 ml. Though the issue only impacted some batches, we are recalling all batches out of an abundance of caution,” P&G Philippines said.
“The potential presence of ethylene glycol in the product may result in adverse drug reactions. That is why even though our inspections and tests are still ongoing, we have decided to proactively recall all batches still in circulation to ensure our consumers only get products that meet P&G’s quality promise,” it added.
Consumers who have purchased the said item are advised to discontinue the use of the product. Return and refund can be initiated by contacting P&G Consumer Care, it said.
Children who have consumed the product and are showing adverse reactions may contact P&G’s consumer care or the FDA.
The US CDC said some of the initial adverse health effects caused by ethylene glycol intoxication include:
- central nervous system depression,
- stupor, and
- respiratory depression
- nausea and vomiting may occur as a result of gastrointestinal irritation.
- severe toxicity may result in coma, loss of reflexes, seizures (uncommon), and irritation of the tissues lining the brain.
P&G said retailers and pharmacies are requested to stop the distribution, sale and use of the product, and return the remaining stocks.
The company advised parents to contact the National Poison Management and Control Center at (02) 8524 1078, and seek urgent medical attention and report to the FDA or P&G Consumer Care if their children exhibit the following after consuming the product:
- abdominal pain
- altered mental state
- symptoms of acute kidney injury like inability to pass or reduced urine
- lower back pain
- additional symptoms of irritability, lethargy, pale appearance, decreased muscle tone, and loss of appetite in younger kids