Pacific Health Sciences Voluntarily Recalls One Lot of Babies' Magic Tea Brand Baby Sleep Gripe Water Dietary Supplement
Reviewed and published by MPB Safety Desk
What parents need to know
Pacific Health Sciences is voluntarily recalling one lot of Babies' Magic Tea brand Baby Sleep Gripe Water, a dietary supplement sold in an amber bottle inside a blue cardboard box with an oral syringe included. This recall affects one specific lot of the product, which can be identified by the lot number printed on the bottom of the box and on a side panel of the bottle.
FDA testing of this lot found ethanol, methanol, and isopropanol that were not declared on the product label, at approximately 8.3% ethanol, 0.35% methanol, and 0.48% isopropanol. These substances were not listed on the label, and 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.
Parents and caregivers should stop using any product from the affected lot 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 the firm.
For full identification details, including the lot number and best before date, as well as contact information for questions or to report a reaction, refer to the official recall notice.
Recall details
From the official U.S. Food and Drug Administration record
- Recall date
- Remedy
- 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.
- Official 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 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.
- Consumer contact
- Pacific Health Sciences 310-457-1775 myorder@pacifichealth.com
Recall details are summarized from official government sources and reviewed by our editors before publishing. Information can change after publication. Always confirm the current status, affected models, and remedy instructions in the official U.S. Food and Drug Administration notice before acting.
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