FDA recall F-1486-2020

Sundial Herbal Products · Class II · food

Product

"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BROOM WEED***1oz.***USES: BREAKS UP INFECTION IN BLADDER & REPRODUCTIVE SYTSEM, VENEREAL DISEASE, FEVER***"; packaged in clear plastic zip-top bags

Reason for recall

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

Distribution

NY

Key facts

Status
Terminated
Initiation date
2020-06-30
Report date
2020-09-09
Termination date
2022-10-26
Voluntary/Mandated
FDA Mandated
Location
Bronx, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1486-2020