Undeclared Alcohol Content
FDA testing found the recalled product contained approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol. None of these substances were listed on the label, according to the recall notice.
"These substances were not listed on the label," the notice states. "Their presence may pose a risk depending on the amount consumed and the age and body weight of the person using the product."
The company warned that exposure to the amounts recommended on the packaging could cause drowsiness, lack of coordination, behavioral changes, nausea, vomiting and abdominal pain. The notice further stated:
"Organic alcohols such as ethanol, methanol, and isopropanol are known to impair normal functioning of the central nervous system, while infant ethanol exposure has been linked to long-term developmental consequences."
Pacific Health Sciences added, "Exposure to higher amounts can increase risk of respiratory depression and other serious adverse health consequences."