FDA recall F-3245-2015

Majopa Industries Corporation · Class I · food

Product

Label reads in part as: "GRAVIOLA EXTRACT***1 FL Oz (30 ml)*** ORIGINAL FORMULA***Manufactured by: Majopa Industries Corp.*** PRODUCT OF PUERTO RICO,USA". Drug claims in the product label are as follows: "Researchers have found that Extracts from Graviola leaves can produce acetogenins which are extremely effective in the treatment of cancer cells. Graviola extract can works like an antibiotic against cancer cells by stopping growth of the enzymes needed for cell growth. It can be:cellular protector, anti tumorous, antiviral. Also can be used as: Digestive stimulant, Strengthens immune system, antifungal, tranquilizer".

Reason for recall

Firm's dietary supplements were being promoted for conditions that caused the products to be drugs under the FD&C Act.

Distribution

Puerto Rico only

Key facts

Status
Terminated
Initiation date
2015-07-31
Report date
2015-09-30
Termination date
2017-03-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Guayama, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-3245-2015