Drug product
SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.
D-165-2013
Product summary
- Firm
- P & J Trading Co
- Event
- Event 63942
- Status
- Terminated
- Classification
- Class I
- Quantity
- unknown
- Official record key
drug-enforcement:D-165-2013
Official wording
Reason: 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.
Code information: There are no manufacturing codes associated with the product.
Distribution pattern: Korea
Derived failure modes
-
Unknown
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.