FDA Recalls Super Hard Capsules Marketed Without Approval
R Thomas Marketing, LLC is recalling Super Hard capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
What this means for you
Illness, injury, or structural failure has been reported. 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
The U.S. Food and Drug Administration (FDA) has issued a recall for Super Hard capsules. The product is packaged in a BIG BOX containing 20 small boxes, with 6 capsules per box, for a total of 120 capsules. It is distributed by R Thomas Marketing, LLC, located in Bronx, NY 10467.
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 product has not been evaluated by the FDA for safety, efficacy, or quality.
The recall covers all lots of the product. It was distributed nationwide via Internet sales. Consumers who have purchased this product should stop using it and contact the distributor for further instructions.
The recalled product
- Product
- Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 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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