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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: One Lot of Babies' Magic Tea Brand Baby Sleep Gripe Water Dietary Supplement by Pacific Health Sciences: Recall - Due to Undeclared Ethanol, Methanol, and Isopropanol
AUDIENCE: Consumer, Patient, Health Care Professional, Pediatric
ISSUE: Pacific Health Sciences is recalling one lot of Babies' Magic Tea brand Baby Sleep Gripe Water dietary supplement. 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.
The affected product was distributed to Secrets of Tea for subsequent distribution through online retailers, including www.secretsoftea.com.
To date, Pacific Health Sciences has received no reports of adverse events associated with this lot.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is marketed as dietary supplement.
RECOMMENDATIONS:
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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.
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Anyone who experiences symptoms after using the product should seek medical attention and contact Pacific Health Sciences.
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For questions or to report a reaction, contact Pacific Health Sciences at 310-457-1775 or myorder@pacifichealth.com.
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Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download the form or call 1-800-332-1088 to request a reporting form, then complete it and return it to the address on the form or submit it by fax to 1-800-FDA-0178.
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