The Las Vegas-based company has two weeks to notify the FDA of its plans to correct the violations.
The drink has more caffeine than a Starbucks Grande coffee and 350% more than Red Bull.
Redux markets Cocaine as "The Legal Alternative" on its Web site, where its descriptions include "Speed in a Can," "Liquid Cocaine" and "Cocaine-Instant Rush." About 500 energy drinks were launched worldwide last year, when the segment's sales stood at $8 billion.
The company also is battling to trademark "cocaine" at the U.S. Patent and Trademark Office.
When 7-Eleven stores pulled the product from its shelves last year, Hannah Kirby, the company's managing partner, said: "We knew it would be controversial. That was the marketing plan, because young adults and teens love controversy."
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