Recall - Babies' Magic Tea (Babies' Magic Tea brand Baby Sleep Gripe Water 4 oz bottle) produced by Pacific Health Sciences - Product contains undeclared ethanol, methanol, and[...]

Summary

Company Announcement

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

The affected product was distributed to Secrets of Tea for subsequent distribution through online retailers, including https://www.secretsoftea.com and Amazon.

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 Information

For questions or to report a reaction, contact Pacific Health Sciences at 310-457-1775 or [email protected], 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 https://www.fda.gov/medwatch/report.htm. To report by mail or fax, download a form at https://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.