Hard Ten Days capsules recalled for lack of FDA approval
R Thomas Marketing, LLC is recalling Hard Ten Days capsules 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
R Thomas Marketing, LLC is recalling Hard Ten Days, a product packaged in a BIG BOX containing 6 small boxes with 6 capsules each (36 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 means the drug has not been evaluated by the FDA for safety, efficacy, or quality.
Consumers who have purchased this product should stop using it and contact the distributor for further instructions. The recall applies to all lots of the product.
The recalled product
- Product
- Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
- Manufacturer
- R Thomas Marketing, LLC
- Category
- Drug — Unapproved Drug
- 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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