Why it was recalled
Firm's dietary supplements were being promoted for conditions that caused the products to be drugs under the FD&C Act.
Product description
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".
Lot numbers, UPCs & expiration codes
02/2020
Where it was sold
Puerto Rico only
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-3245-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 31, 2015
- FDA report date
- Sep 30, 2015
- Quantity
- 500 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Majopa Industries Corporation
Original FDA data
Every field from FDA enforcement report F-3245-2015, exactly as published.
Show all FDA fields
- City
- Guayama
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 71918
- Address
- Calle Ashford #62 sur
- Code information
- 02/2020
- Postal code
- 00784
- Report date
- Sep 30, 2015
- Product type
- Food
- Recall number
- F-3245-2015
- Classification
- Class I
- Recalling firm
- Majopa Industries Corporation
- Product quantity
- 500 bottles
- Termination date
- Mar 29, 2017
- Reason for recall
- Firm's dietary supplements were being promoted for conditions that caused the products to be drugs under the FD&C Act.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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".
- Distribution pattern
- Puerto Rico only
- Recall initiation date
- Jul 31, 2015
- Initial firm notification
- Telephone
- Center classification date
- Sep 22, 2015