D-165-2013 Class I Terminated
FDA drug recall D-165-2013 was initiated by P & J Trading Co on December 19, 2012 and is designated Class I. 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. m… The recall status is terminated (terminated March 25, 2013). Affected quantity: unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- February 27, 2013
- Initiation Date
- December 19, 2012
- Termination Date
- March 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
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.
Distribution Pattern
Korea
Code Information
There are no manufacturing codes associated with the product.