SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buen...

FDA Recall #D-165-2013 — Class I — December 19, 2012

Recall #D-165-2013 Date: December 19, 2012 Classification: Class I Status: Terminated

Product Description

SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.

Reason for Recall

Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.

Recalling Firm

P & J Trading Co — Fullerton, CA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

unknown

Distribution

Korea

Code Information

There are no manufacturing codes associated with the product.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated