The Recall Desk
CriticalFDA (Drugs)·D-0887-2016·Announced 2016-06-01

FDA Recalls Stree Overlord Capsules Marketed Without Approval

R Thomas Marketing, LLC is recalling Stree Overlord capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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) or 4 (Severe); however, the rubric states 'If the agency's own classification is FDA Class I... never go below 4' and typically Class I implies a reasonable probability of serious adverse health consequences or death, aligning with the Critical label in the provided mapping where 5=Critical. Wait, the rubric says 5=Critical for 'FDA Class I'. Let me re-read. '5 Critical: FDA Class I...'. Yes, FDA Class I maps to 5.

Plain-English summary

R Thomas Marketing, LLC is recalling Stree Overlord, a product packaged in 10 small boxes containing 1 capsule per box. The product was distributed nationwide via Internet sales.

The FDA is recalling this product because it 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 Stree Overlord should stop using the product and contact the distributor for further instructions.

The recalled product

Product
Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

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.

See all 24 products in this recall →

Same manufacturer · R Thomas Marketing, LLC

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