Recall record at a glance
| Official record | F-3245-2015 |
|---|---|
| Category | Food Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Majopa Industries Corporation |
| Report date | Sep 30, 2015 |
| Recall initiation date | Jul 31, 2015 |
| Quantity | 500 bottles |
| Location | Guayama, PR, United States |
Official 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".
Why the product was recalled
Firm's dietary supplements were being promoted for conditions that caused the products to be drugs under the FD&C Act.
Distribution information
Puerto Rico only
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Telephone.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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