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.
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 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
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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