FDA Recalls Mojo Risen Distributed Without Approved New Drug Application
R Thomas Marketing, LLC is recalling Mojo Risen capsules nationwide because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a minimum severity score of 4 (Severe).
Plain-English summary
R Thomas Marketing, LLC is recalling Mojo Risen, a product packaged in a BIG BOX containing 24 individual cards with 2 capsules per card (48 capsules total). The product was distributed nationwide via Internet sales.
The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This indicates the product has not been evaluated by the FDA for safety, efficacy, or quality.
Consumers who have purchased Mojo Risen should stop using the product and contact the distributor for further instructions.
The recalled product
- Product
- Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
- Manufacturer
- R Thomas Marketing, LLC
- Category
- Drug — Unapproved Supplement
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by R Thomas Marketing, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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