Status
Terminated
Drug Enforcement D-165-2013
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.
Classification
Class I
Report Date
February 27, 2013
Termination Date
March 25, 2013
Product Information
- Product description
- SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.
- Product quantity
- unknown
- 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 initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Korea
Location & Firm
- Recalling firm
- P & J Trading Co
- Address
-
1941 W Commonwealth Ave, Suite B
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-165-2013
- Event ID
- 63942
- Recall initiation date
- December 19, 2012
- Center classification date
- February 15, 2013
- Code info
- There are no manufacturing codes associated with the product.
- More code info
- —