FDA Recall D-165-2013
P & J Trading Co · Fullerton, CA
Class I — life-threatening Terminated 96 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-165-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Korea
- Recall initiated
- 2012-12-19
- Classified by FDA Center
- 2013-02-15
- FDA published
- 2013-02-27
- Terminated
- 2013-03-25
- Recalling firm
- P & J Trading Co
- Firm location
- Fullerton, CA