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Recall Observatory FDA recall evidence

Food product

"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***JACK IN THE BUSH***1oz.***USES: COLD MEDICINE (ESP. IN CHILDREN), CALMS THE NERVES, RELIEVES DEPRESSION***"; packaged in clear plastic zip-top bags

F-1483-2020

June 30, 2020

Class II

Product summary

Firm
Sundial Herbal Products
Event
Event 85882
Status
Terminated
Classification
Class II
Quantity
Unknown
Official record key
food-enforcement:F-1483-2020

Official wording

Reason: Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Code information: Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.

Distribution pattern: NY

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    misbranded