The Recall Desk
CriticalFDA (Drugs)·D-165-2013·Announced 2013-02-27

Dietary Supplement Slimdia Revolution Recalled for Containing Unapproved Drug Sibutramine

P & J Trading Co is recalling Slimdia Revolution capsules because they contain sibutramine, a drug removed from the U.S. market for safety reasons.

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 mandates a severity score of 5 according to the rubric.

Plain-English summary

P & J Trading Co is recalling all lots of Slimdia Revolution capsules, a dietary supplement marketed by Yerba Naturals. The product is being recalled because it contains sibutramine, a previously approved FDA drug that was removed from the U.S. marketplace for safety reasons. The presence of this substance makes the product an unapproved new drug.

The recall involves 30-count bottles of Slimdia Revolution capsules. The source text indicates that the product was marketed in Korea. There are no manufacturing codes associated with the product.

Consumers who have purchased Slimdia Revolution capsules should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.
Manufacturer
P & J Trading Co
Category
Drug — Dietary Supplement
Hazard

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)

  • There are no manufacturing codes associated with the product.

Distribution

Distribution scope not specified by the agency.

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Same hazard · unapproved drug

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