The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0904-2016·Announced 2016-06-01

Tiger King capsules recalled for lack of FDA approval

R Thomas Marketing, LLC is recalling Tiger King 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 severity score of 5 (Critical) regardless of other factors.

Plain-English summary

R Thomas Marketing, LLC is recalling Tiger King, a dietary supplement packaged in a BIG BOX containing 10 small bottles with 10 capsules each (100 capsules total). The product was distributed nationwide via Internet sales. All lots are affected by this recall.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This means the product has not undergone the FDA's review process to ensure its safety, efficacy, and quality.

Consumers who have purchased Tiger King should stop using the product and return it to the place of purchase for a refund or contact the distributor for further instructions.

The recalled product

Product
Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules), 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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