COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.
Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Dietary Supplements
- Reason for Announcement:
- Recall Reason DescriptionProduct contains undeclared ethanol, methanol, and isopropanol
- Company Name:
- Pacific Health Sciences
- Brand Name:
- Brand Name(s)Babies’ Magic Tea
- Product Description:
- Product DescriptionBabies’ Magic Tea brand Baby Sleep Gripe Water 4 oz bottle
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.
[Hazard statement]:
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. Exposure to higher amounts can increase risk of respiratory depression and other serious adverse health consequences.
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 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 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.
Product Photos
Product photographs and package-identification images are available with the official FDA notice.
