FDA recall F-1445-2020

Sundial Herbal Products · Class II · food

Product

Bitter Kola (Arogbo); "***a Natural Antibiotic kills all bacteria, virus, Infections and prevent them***it's a good antidote to all poisons, it's used against stomach problem like EBOLA, Colitis, Diarrhea; dysentery etc. It suppresses the Bacteria that causes them***strengthen immune system with HIV AIDS***"

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-1445-2020