FDA Recalls Zhen Gong Fu for Lack of Approved New Drug Application
R Thomas Marketing, LLC is recalling Zhen Gong Fu 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
R Thomas Marketing, LLC is recalling Zhen Gong Fu, a product packaged in a big box containing 16 small boxes with 2 capsules each (32 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 product has not been evaluated by the FDA for safety, efficacy, or quality.
Consumers who have purchased Zhen Gong Fu should stop using the product and contact the distributor for further instructions.
The recalled product
- Product
- Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 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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