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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Alkaloids Chewable Tablets—White Vein by Shaman Botanicals: Recall - Due to Undeclared Concentration of 7-Hydroxymitragynine (7-OH)
AUDIENCE: Consumer, Health Care Professional, Pharmacy
ISSUE: Shaman Botanicals is recalling one lot (Lot B# AAW.501.3) of Alkaloids Chewable Tablets—White Vein because recent testing showed that the Alkaloids Chewable Tablets—White Vein product contains 7-Hydroxymitragynine (7-OH) in an amount more than the declared value of 7.5 mg/tablet.
Risk Statement: Use of the Alkaloids Chewable Tablets—White Vein product could result in consumers ingesting a higher dose than intended, which could result in adverse health effects.
Shaman Botanicals has not received any reports of adverse events related to this lot of Alkaloids Chewable Tablets—White Vein.
The Alkaloids Chewable Tablets—White Vein product was distributed nationwide to wholesalers, retailers, and consumers via online sales.
For more information about this recall/alert, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is sold as a dietary supplement.
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this dietary supplement product.
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
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Wholesalers, distributors, retailers, and consumers that have the Alkaloids Chewable Tablets—White Vein product that is being recalled should quarantine the product, stop using it, and return it to Shaman Botanicals.
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To receive a full refund or replacement product, please go to the attached URL to register your return. https://recall.cbdamericanshaman.com/.
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Consumers with questions regarding this recall can contact Shaman Botanicals at Telephone: 855-427-7386, Email: Quality@CBDAmericanShaman.com, https://recall.cbdamericanshaman.com/
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Health care professionals and consumers 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 form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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