FDA-Food2020-09-09Class II

"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PURPLE SAGE***1 oz.***USES: DEPRESSION, INSECT BITES, INSOMNIA, RELIEVES CONGESTION***"; packaged in clear plastic zip-top bags

Sundial Herbal Products
Hazard

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

Sold states
NY
Affected count
Unknown
Manufactured in
3609 Boston Rd, N/A, Bronx, NY, United States
Products
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PURPLE SAGE***1 oz.***USES: DEPRESSION, INSECT BITES, INSOMNIA, RELIEVES CONGESTION***"; packaged in clear plastic zip-top bags

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1476-2020

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