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Recall Observatory FDA recall evidence

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".

F-3245-2015

July 31, 2015

Class I

Product summary

Firm
Majopa Industries Corporation
Event
Event 71918
Status
Terminated
Classification
Class I
Quantity
500 bottles
Official record key
food-enforcement:F-3245-2015

Official wording

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

Code information: 02/2020

Distribution pattern: Puerto Rico only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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