United StatesWhat's being recalled
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.
Distribution
Contact Information
For questions or to report a reaction, contact Pacific Health Sciences at 310-457-1775 or myorder@pacifichealth.com, Monday through Thursday, 9:30 a.m. to 5:00 p.m. Pacific Time.
Adverse reactions may also be reported to the FDA MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm. To report by mail or fax, download a form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request one.
This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
Consumers:
Pacific Health Sciences
310-457-1775
myorder@pacifichealth.com
The hazard
Product contains undeclared ethanol, methanol, and isopropanol
What to do
What Consumers Should Do
Consumers, parents, and caregivers should stop using any product from Lot 25122bw and either discard it or return it to the place of purchase for a refund.
Anyone who experiences symptoms after using the product should seek medical attention and contact Pacific Health Sciences.
Contact: Consumers: Pacific Health Sciences 310-457-1775 myorder@pacifichealth.com
Where it was sold
The affected product was distributed to Secrets of Tea for subsequent distribution through online retailers, including www.secretsoftea.com and Amazon.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration, collected from U.S. Food and Drug Administration. Check the original before you act on it.
Read the official notice (opens in a new tab)