Agency classClass IOur severity:Critical FDA (Drugs)·D-0895-2016·Announced 2016-06-01

FDA Recalls Black Ant King for Lack of Approved New Drug Application

R Thomas Marketing, LLC is recalling Black Ant 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 indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 5.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Black Ant King, a product packaged in BIG BOX format containing 120 capsules. The product is distributed by R Thomas Marketing, LLC, located in Bronx, NY 10467.

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 drug has not been evaluated by the FDA for safety, efficacy, or quality.

The recall covers all lots of the product, which were 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: Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Manufacturer: R Thomas Marketing, LLC
Category: Drug — Unapproved Drug
Hazard: unapproved-drug

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

See all →

Severe
Man King capsules recalled for lack of FDA approval
FDA (Drugs) · 2016-06-01
Severe
FDA Recalls Black Storm Capsules Marketed Without Approval
FDA (Drugs) · 2016-06-01
Severe
FDA Recalls Zhen Gong Fu for Lack of Approved New Drug Application
FDA (Drugs) · 2016-06-01
Severe
Bull's Genital Recalled for Marketing Without FDA Approval
FDA (Drugs) · 2016-06-01
Severe
Plant Vigra Recalled for Lack of FDA Approval
FDA (Drugs) · 2016-06-01

Same hazard · unapproved drug