The Recall Desk
CriticalFDA (Drugs)·D-0894-2016·Announced 2016-06-01

FDA Recalls Unapproved Male Enhancement Product Sold Nationwide Online

The FDA is recalling 'Bigger Longer More Time More Sperms' because it was 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 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) is recalling the product 'Bigger Longer More Time More Sperms,' which is packaged in a BIG BOX containing 6 small boxes with 6 capsules each (36 capsules total). The product 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 product was distributed nationwide via Internet sales. All lots are affected. Consumers who have purchased this product should stop using it and contact the distributor for further instructions.

The recalled product

Product
Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 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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