Pacific Health Sciences Voluntarily Recalls One Lot of Babies’ Magic Tea Brand Baby Sleep Gripe Water Dietary Supplement
Pacific Health Sciences is voluntarily recalling one lot of Babies’ Magic Tea brand Baby Sleep Gripe Water dietary supplement.
Product Information
Product: Babies’ Magic Tea brand Baby Sleep Gripe Water
Lot Number: 25122bw
Best Before: 12/2028
Package: 4 fl oz (approximately 118 mL) amber bottle inside a blue cardboard box. The lot number appears on the bottom of the box and on a side panel of the bottle. An oral syringe is included in the box.
Reason for Recall
FDA testing of this lot identified ethanol, methanol, and isopropanol that were not declared on the product label. Measured levels were approximately 8.3% ethanol, 0.35% methanol, and 0.48% isopropanol. 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.
To date, Pacific Health Sciences has received no reports of adverse events associated with this lot.