1 lot of baby product voluntarily recalled over alcohol content
The product was recalled after FDA testing found undeclared alcohol.
One lot of a dietary supplement for babies has been voluntarily recalled due to alcohol content.
Pacific Health Sciences announced this week the company is voluntarily recalling one lot of its Babies' Magic Tea brand Baby Sleep Gripe Water, after it said Food and Drug Administration testing identified undeclared alcohols in the recalled product, including ethanol, methanol and isopropanol.
"Measured levels were approximately 8.3% ethanol, 0.35% methanol, and 0.48% isopropanol," the company said in its announcement, which was published on the FDA website Wednesday. "These substances were not listed on the label. Their presence may pose a risk depending on the amount consumed and the age and body weight of the person using the product."
The recalled product was packaged in 4-fluid-ounce amber bottles (about 118 milliliters) inside blue cardboard boxes and came with an oral syringe, the company said. The product was distributed through online retailers, including the Secrets of Tea website and Amazon.
Only one lot of the product is impacted by the recall, Pacific Health Sciences said in its announcement. The lot number, 25122bw, can be found on the bottom and side panel of the blue carboard boxes, according to the company, and the product has a "best before" date of December 2028.
The company announcement notes that 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."
"Exposure to the amounts recommended on this product's packaging can induce drowsiness, incoordination, behavioral changes, nausea, vomiting, and abdominal pain," the announcement reads. "Exposure to higher amounts can increase risk of respiratory depression and other serious adverse health consequences."
Pacific Health Sciences said it has not received any reports of adverse events in connected with the recalled product to date.
Pacific Health Sciences recommended anyone in possession of the recalled product stop using the product and discard it or return it to the place of purchase for a refund. The company also said anyone who experiences symptoms after having used the recalled product should seek medical attention and contact the company.
Pacific Health Sciences can be reached via phone at (310) 457-1775 or by email at myorder@pacifichealth.com, from Monday through Thursday, between 9:30 a.m. to 5 p.m. PT.
ABC News has reached out to Pacific Health Sciences for comment.